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Official Journal of the European Union, C 186, 23 July 2008

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		ISSN 1725-2423
Official Journal of the European Union		C 186

English edition	Information and Notices	Volume 51 23 July 2008

Notice No	Contents	page
	II Information
	INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2008/C 186/01	Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections	1

2008/C 186/02	Initiation of proceedings (Case COMP/M.5046 — Friesland/Campina) ( 1 )	5

2008/C 186/03	Non-opposition to a notified concentration (Case COMP/M.5066 — Eurogate/APMM) ( 1 )	6

2008/C 186/04	Non-opposition to a notified concentration (Case COMP/M.5179 — Eramet/Tinfos) ( 1 )	6

	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2008/C 186/05	Euro exchange rates	7

2008/C 186/06	Communication from the Commission to all farmers concerning set aside from 2009	8

	NOTICES FROM MEMBER STATES
2008/C 186/07	Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices ( 1 )	9

2008/C 186/08	Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices ( 1 )	25

2008/C 186/09	Commission communication in the framework of the implementation of the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices ( 1 )	28

	V Announcements
	PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY
	Commission
2008/C 186/10	Notice of initiation of an anti-dumping proceeding concerning imports of sodium metal originating in the United States of America	32

2008/C 186/11	Notice of initiation of an anti-subsidy proceeding concerning imports of sodium metal originating in the United States of America	35

	PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY
	Commission
2008/C 186/12	Prior notification of a concentration (Case COMP/M.5201 — Total Produce/Haluco/JV) ( 1 )	37

2008/C 186/13	Prior notification of a concentration (Case COMP/M.5155 — Mondi/Loparex Assets) ( 1 )	38

2008/C 186/14	Prior notification of a concentration (Case COMP/M.5268 — Goldman Sachs/PAI/Xella International) — Candidate case for simplified procedure ( 1 )	39

2008/C 186/15	Prior notification of a concentration (Case COMP/M.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales) — Candidate case for simplified procedure ( 1 )	40

	Corrigenda
2008/C 186/16	Corrigendum to notice for the attention of the persons, groups and entities on the list provided for in Article 2(3) of Council Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (OJ C 179, 16.7.2008)	41


	(1) Text with EEA relevance

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

23.7.2008

Official Journal of the European Union

C 186/1

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

Cases where the Commission raises no objections

(2008/C 186/01)

Date of adoption of the decision

13.2.2008

Reference number of the aid

N 130a/07

Member State

Finland

Region

—

Title (and/or name of the beneficiary)

Tuki metsäalalle

Legal basis

Laki kestävän metsätalouden rahoituksesta; Asetus kestävän metsätalouden rahoituksesta

Type of measure

Aid scheme

Objective

Maintaining and restoring ecological, protective and recreational functions of forests, biodiversity and healthy forest ecosystems

Form of aid

Subsidy

Budget

EUR 90 million annually

Intensity

Variable

Duration

Until 31.12.2013

Economic sectors

Forestry

Name and address of the granting authority

Maa- ja metsätalousministeriö

PL 30

FI-00023 Valtioneuvosto (Helsinki)

Other information

—

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

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

19.3.2008

Reference number of the aid

N 314/07

Member State

Cyprus

Region

—

Title (and/or name of the beneficiary)

Καθεστώς ενισχύσεων για ενέργειες προώθησης και διαφήμισης γεωργικών προϊόντων στην εσωτερική αγορά και τις τρίτες χώρες

Legal basis

Προεδρικό διάταγμα

Type of measure

Aid scheme

Objective

To grant aid for promotion and advertising measures

Form of aid

Direct grant

Budget

EUR 14 500 000

Intensity

Up to 100 % for promotion aid

Up to 40 % for advertising aid

Duration

5 years

Economic sectors

Agriculture

Name and address of the granting authority

Υπουργείο Εμπορίου, Βιομηχανίας και Τουρισμού/Ministry of Commerce, Industry and Tourism

Υπηρεσία Εμπορίου — Κλάδος προώθησης γεωργικών προϊόντων/Trade Service — Promotion of Agricultural Products Section

CY-1421 Λευκωσία/CY-1421 Nicosia

Other information

—

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

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

13.2.2008

Aid number

N 438/A/07

Member State

Federal Republic of Germany

Region

Mecklenburg-Vorpommern

Title (and/or name of the beneficiary)

Forstmaßnahmen

Legal basis

Richtlinie zur Förderung forstwirtschaftlicher Maßnahmen im Rahmen des Europäischen Landwirtschaftsfonds für die Entwicklung des ländlichen Raums (FöRiForst-ELER M-V)

Type of measure

Aid scheme

Objective

To preserve, restore or improve the ecological, protective and leisure-related functions of the forest, the diversity of species and a healthy forest eco-system

Form of aid

Subsidy

Budget

EUR 32 800 000

Intensity

Variable

Duration

2007-2015

Economic sectors

Agriculture

Name and address of the granting authority

Ministerium für Landwirtschaft, Umwelt und Verbraucherschutz M-V

D-19053 Schwerin

Other information

—

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

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

30.1.2008

Aid number

N 445/07

Member State

Federal Republic of Germany

Region

Niedersachsen

Title (and/or name of the beneficiary)

Forstbeihilfen

Legal basis

1.	Richtlinie über die Gewährung von Zuwendungen zur Förderung forstwirtschaftlicher Maßnahmen in den Ländern Niedersachsen und Bremen

2.	Maßnahme „Wiederaufbau des forstwirtschaftlichen Potenzials und Einführung vorbeugender Aktionen“, „PROFIL 2007-2013“ Programm zur Förderung im ländlichen Raum Niedersachsen und Bremen

Type of measure

Aid scheme

Objective

1.	To preserve, restore or improve the ecological, protective and leisure-related functions of the forest, the diversity of species and a healthy forest eco-system.

2.	To restore forestry potential and introduce prevention actions (Code 226) in accordance with Article 36(b)(vi) and Article 48 of the Regulation (EC) No 1698/2005

Form of aid

Subsidy

Budget

EUR 4 500 000

Maximum aid intensity

100 %

Duration

2007-2013

Economic sectors

Agriculture

Name and address of the granting authority

Landwirtschaftskammer Niedersachsen

Geschäftsbereich Förderung

Johannssenstr. 10

D-30159 Hannover

Other information

—

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

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

3.6.2008

Reference number of the aid

N 514/07

Member State

Hungary

Region

—

Title (and/or name of the beneficiary)

2007. évben tavaszi fagykárt szenvedett szőlő és gyümölcstermesztők által igénybe vehető kedvezményes hitel

Legal basis

—	A földművelésügyi és vidékfejlesztési miniszter …/2007. (…) FVM rendelete a 2007. évben tavaszi fagykárt szenvedett szőlő és gyümölcstermesztők hitelhez jutási lehetőségéről;

—	A nemzeti agrárkár-enyhítési rendszerről szóló 2006. évi LXXXVIII. törvény

Type of measure

Aid scheme

Objective

Compensation for damages caused by the 2007 spring frost to grape and fruit producers

Form of aid

Interest rate subsidy and State guarantee

Budget

Overall budget: HUF 160 million

Intensity

The aid intensity of the preferential loan and the State guarantee will be 22 %. The overall aid intensity resulting from the damage compensation provided by the National Damage Mitigation Act, the preferential loan and the State guarantee must not exceed 80 % of the production loss

Duration

Three months from the approval by the Commission

Economic sectors

Agriculture

Name and address of the granting authority

Ministry of Agriculture and Rural Development

Kossuth Lajos tér 11

H-1055 Budapest

Other information

—

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

http://ec.europa.eu/community_law/state_aids/

23.7.2008

Official Journal of the European Union

C 186/5

Initiation of proceedings

(Case COMP/M.5046 — Friesland/Campina)

(Text with EEA relevance)

(2008/C 186/02)

On 17 July 2008, the Commission decided to initiate proceedings in the above-mentioned case after finding that the notified concentration raises serious doubts as to its compatibility with the common market. The initiation of proceedings opens a second phase investigation with regard to the notified concentration, and is without prejudice to the final decision on the case. The decision is based on Article 6(1)(c) of Council Regulation (EC) No 139/2004.

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

In order to be fully taken into account in the procedure, observations should reach the Commission not later than 15 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference COMP/M.5046 — Friesland/Campina, to the following address:

Commission of the European Communities

Competition DG

Merger Registry

Rue Joseph II/Jozef II-straat 70

B-1000 Brussels

23.7.2008

Official Journal of the European Union

C 186/6

Non-opposition to a notified concentration

(Case COMP/M.5066 — Eurogate/APMM)

(Text with EEA relevance)

(2008/C 186/03)

On 5 June 2008, 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 website (http://ec.europa.eu/comm/competition/mergers/cases/). This website 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 32008M5066. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

23.7.2008

Official Journal of the European Union

C 186/6

Non-opposition to a notified concentration

(Case COMP/M.5179 — Eramet/Tinfos)

(Text with EEA relevance)

(2008/C 186/04)

On 3 July 2008, 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 website (http://ec.europa.eu/comm/competition/mergers/cases/). This website 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 32008M5179. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

23.7.2008

Official Journal of the European Union

C 186/7

Euro exchange rates (1)

22 July 2008

(2008/C 186/05)

1 euro=

	Currency	Exchange rate
USD	US dollar	1,5919
JPY	Japanese yen	169,26
DKK	Danish krone	7,4610
GBP	Pound sterling	0,79355
SEK	Swedish krona	9,4763
CHF	Swiss franc	1,6174
ISK	Iceland króna	126,67
NOK	Norwegian krone	8,0555
BGN	Bulgarian lev	1,9558
CZK	Czech koruna	23,013
EEK	Estonian kroon	15,6466
HUF	Hungarian forint	229,07
LTL	Lithuanian litas	3,4528
LVL	Latvian lats	0,7034
PLN	Polish zloty	3,2308
RON	Romanian leu	3,5635
SKK	Slovak koruna	30,363
TRY	Turkish lira	1,9054
AUD	Australian dollar	1,6284
CAD	Canadian dollar	1,5943
HKD	Hong Kong dollar	12,4119
NZD	New Zealand dollar	2,0876
SGD	Singapore dollar	2,1540
KRW	South Korean won	1 618,96
ZAR	South African rand	12,0362
CNY	Chinese yuan renminbi	10,8595
HRK	Croatian kuna	7,2175
IDR	Indonesian rupiah	14 562,70
MYR	Malaysian ringgit	5,1530
PHP	Philippine peso	70,760
RUB	Russian rouble	36,9075
THB	Thai baht	53,090
BRL	Brazilian real	2,5168
MXN	Mexican peso	16,1339

(1)

Source: reference exchange rate published by the ECB.

23.7.2008

Official Journal of the European Union

C 186/8

Communication from the Commission to all farmers concerning set aside from 2009

(2008/C 186/06)

The Commission wishes to draw the attention of Community farmers to the Health Check proposal (COM(2008) 306 final (1)) to abolish compulsory set aside as from 2009 onwards. The proposal was adopted by the Commission on 20 May 2008 and it is currently under discussion in the Council, the European Parliament and the other European Institutions.

The proposal is the logical follow-up of Council Regulation (EC) No 1107/2007 (2) fixing the rate for compulsory set aside at zero in 2008.

Under the proposal, farmers will not be obliged to set aside land from production in order to be entitled to the amount fixed by the set-aside entitlements. The set-aside entitlements will be turned to normal entitlements. Farmers could already benefit from the measure as from their autumn 2008 and spring 2009 sowings.

(1) COM(2008) 306: Proposal for a Council Regulation establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers; proposal for a Council Regulation on modifications to the common agricultural policy by amending Regulations (EC) No 320/2006, (EC) No 1234/2007, (EC) No 3/2008 and (EC) No […]/2008; proposal for a Council Regulation amending Regulation (EC) No 1698/2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD).

(2) Council Regulation (EC) No 1107/2007 of 26 September 2007 derogating from Regulation (EC) No 1782/2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers, as regards set aside for the year 2008 (OJ L 253, 28.9.2007, p. 1).

NOTICES FROM MEMBER STATES

23.7.2008

Official Journal of the European Union

C 186/9

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

(Text with EEA relevance)

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

(2008/C 186/07)

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 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 455-3:2006 Medical gloves for single use — Part 3: Requirements and testing for biological evaluation	EN 455-3:1999	Date expired (30.6.2007)
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 + A1:1998	Date expired (30.4.2002)
CEN	EN 556-1:2001/AC:2006
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 737-4:1998 Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems	—
CEN	EN 794-1:1997 Lung ventilators — Part 1: Particular requirements for critical care ventilators	—
CEN	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	—
CEN	EN 794-3:1998/A1:2005	Note 3	Date expired (31.12.2005)
CEN	EN 980:2008 Symbols for use in the labelling of medical devices	EN 980:2003	31.5.2010
CEN	EN 1041:1998 Information supplied by the manufacturer with medical devices	—
CEN	EN 1060-1:1995 Non-invasive sphygmomanometers — Part 1: General requirements	—
CEN	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 1060-3:1997/A1:2005	Note 3	Date expired (30.6.2006)
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 1282-2:2005 Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified)	EN 1282-2:1997	Date expired (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 1789:2007 Medical vehicles and their equipment — Road ambulances	EN 1789:1999	Date expired (30.11.2007)
CEN	EN 1820:2005 Anaesthetic reservoir bags (ISO 5362:2000, modified)	EN 1820:1997	Date expired (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	—
CEN	EN 1970:2000/A1:2005	Note 3	Date expired (30.9.2005)
CEN	EN 1985:1998 Walking aids — General requirements and test methods	—
CEN	EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)	—
CEN	EN ISO 4074:2002 Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002)	EN 600:1996	Date expired (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 5356-2:2007 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)	EN 1281-2:1995	Date expired (29.2.2008)
CEN	EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)	EN 739:1998	30.6.2010
CEN	EN ISO 5360:2007 Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006)	EN 1280-1:1997	Date expired (30.6.2008)
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 5840:2005 Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005)	EN 12006-1:1999	Date expired (30.6.2006)
CEN	EN ISO 7197:2006 Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006)	—
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 7396-1:2007 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)	EN 737-3:1998	30.4.2009
CEN	EN ISO 7396-2:2007 Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)	EN 737-2:1998	30.4.2009
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 7886-4:2006 Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)	—
CEN	EN ISO 8185:2007 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007)	EN ISO 8185:1997	Date expired (31.1.2008)
CEN	EN ISO 8359:1996 Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996)	—
CEN	EN ISO 8536-4:2007 Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)	—
CEN	EN ISO 8835-2:2007 Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)	EN 740:1998	31.5.2009
CEN	EN ISO 8835-3:2007 Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)	EN 740:1998	31.5.2009
CEN	EN ISO 8835-4:2004 Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)	—
CEN	EN ISO 8835-4:2004/AC:2006
CEN	EN ISO 8835-5:2004 Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004)	—
CEN	EN ISO 8835-5:2004/AC:2006
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	Date expired (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 10328:2006 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods (ISO 10328:2006)	—
CEN	EN ISO 10524-1:2006 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)	EN 738-1:1997	31.10.2008
CEN	EN ISO 10524-2:2006 Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)	EN 738-2:1998	31.10.2008
CEN	EN ISO 10524-3:2006 Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)	EN 738-3:1998	31.10.2008
CEN	EN ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators (ISO 10524-4:2008)	EN 738-4:1998	30.6.2010
CEN	EN ISO 10535:2006 Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:2006)	EN ISO 10535:1998	Date expired (30.6.2007)
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 10993-4:2002/A1:2006	Note 3	Date expired (31.1.2007)
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 10993-6:2007 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007)	EN 30993-6:1994	Date expired (31.10.2007)
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 10993-10:2002/A1:2006	Note 3	Date expired (31.1.2007)
CEN	EN ISO 10993-11:2006 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)	EN ISO 10993-11:1995	Date expired (28.2.2007)
CEN	EN ISO 10993-12:2007 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007)	EN ISO 10993-12:2004	Date expired (31.5.2008)
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 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)	—
CEN	EN ISO 11135-1:2007 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)	EN 550:1994	31.5.2010
CEN	EN ISO 11137-1:2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)	EN 552:1994	30.4.2009
CEN	EN ISO 11137-2:2007 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 1.8.2006)	—
CEN	EN ISO 11138-2:2006 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)	—
CEN	EN ISO 11138-3:2006 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)	—
CEN	EN ISO 11140-1:2005 Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)	EN 867-2:1997	Date expired (31.1.2006)
CEN	EN ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)	EN 867-3:1997	Date expired (30.9.2007)
CEN	EN ISO 11197:2004 Medical supply units (ISO 11197:2004)	EN 793:1997	Date expired (30.6.2005)
CEN	EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)	EN 868-1:1997	Date expired (30.4.2007)
CEN	EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)	—
CEN	EN ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)	EN 1174-1:1996 EN 1174-2:1996 EN 1174-3:1996	Date expired (31.10.2006)
CEN	EN ISO 11810-2:2007 Lasers and laser-related equipment — Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers — Part 2: Secondary ignition (ISO 11810-2:2007)	—
CEN	EN ISO 11979-8:2006 Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006)	EN 13503-8:2000	Date expired (31.1.2007)
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 12006-2:1998 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 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 12322:1999 In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media	—
CEN	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 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 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 ISO 12870:2004/AC: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 ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)	EN 46003:1999 EN ISO 13485:2000 EN ISO 13488:2000	31.7.2009
CEN	EN ISO 13485:2003/AC:2007
CEN	EN 13544-1:2007 Respiratory therapy equipment — Part 1: Nebulizing systems and their components	EN 13544-1:2001	Date expired (31.10.2007)
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 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 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements	—
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 14561:2006 Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2)	—
CEN	EN 14562:2006 Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2)	—
CEN	EN ISO 14602:1998 Non-active surgical implants — Implants for Osteosynthesis — Particular requirements (ISO 14602:1998)	—
CEN	EN ISO 14607:2007 Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007)	—
CEN	EN ISO 14630:2008 Non-active surgical implants — General requirements (ISO 14630:2008)	EN ISO 14630:2005	31.7.2008
CEN	EN 14683:2005 Surgical masks — Requirements and test methods	—
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 14931:2006 Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing	—
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 14971:2007 Medical devices — Application of risk management to medical devices (ISO 14971:2007)	EN ISO 14971:2000	31.3.2010
CEN	EN ISO 15001:2004 Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003)	—
CEN	EN ISO 15004-1:2006 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)	EN ISO 15004:1997	Date expired (31.12.2006)
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 15225:2000/A1:2004	Note 3	Date expired (31.8.2004)
CEN	EN 15424:2007 Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices	—
CEN	EN 15546-1:2008 Small bore connectors for liquids and gases in healthcare applications — Part 1 — General Requirements	—
CEN	EN ISO 15747:2005 Plastics containers for intravenous injection (ISO 15747:2003)	—
CEN	EN ISO 15883-1:2006 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)	—
CEN	EN ISO 15883-2:2006 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)	—
CEN	EN ISO 15883-3:2006 Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)	—
CEN	EN ISO 15883-4:2008 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)	—
CEN	EN ISO 16201:2006 Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006)	—
CEN	EN ISO 17510-1:2007 Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)	EN ISO 17510-1:2002	Date expired (30.4.2008)
CEN	EN ISO 17510-2:2007 Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007)	EN ISO 17510-2:2003	Date expired (30.4.2008)
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 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)	EN 554:1994	31.8.2009
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 ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005)	EN 12218:1998	Date expired (30.6.2008)
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)	—
CEN	EN 20594-1:1993/A1:1997	Note 3	Date expired (31.5.1998)
CEN	EN ISO 21171:2006 Medical gloves — Determination of removable surface powder (ISO 21171:2006)	—
CEN	EN ISO 21534:2007 Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007)	EN 12010:1998	Date expired (31.3.2008)
CEN	EN ISO 21535:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007)	EN 12563:1998	Date expired (31.3.2008)
CEN	EN ISO 21536:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007)	EN 12564:1998	Date expired (31.3.2008)
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 12598:1999 EN 864:1996 EN ISO 11196:1997	Date expired (31.5.2005)
CEN	EN ISO 21647:2004/AC:2006
CEN	EN ISO 21649:2006 Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006)	—
CEN	EN ISO 21969:2006 High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)	EN 13221:2000	Date expired (31.12.2007)
CEN	EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007)	EN 12442-1:2000	Date expired (30.6.2008)
CEN	EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)	EN 12442-2:2000	Date expired (30.6.2008)
CEN	EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)	EN 12442-3:2000	Date expired (30.6.2008)
CEN	EN ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods (ISO 22523:2006)	EN 12523:1999	Date expired (30.4.2007)
CEN	EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)	—
CEN	EN ISO 22612:2005 Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005)	—
CEN	EN ISO 22675:2006 Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods (ISO 22675:2006)	—
CEN	EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)	EN 13328-1:2001	30.9.2008
CEN	EN ISO 23328-2:2008 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002)	EN 13328-2:2002	30.9.2008
CEN	EN ISO 23747:2007 Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)	EN 13826:2003	Date expired (31.1.2008)
CEN	EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)	—
CEN	EN 27740:1992/A1:1997	Note 3	Date expired (31.5.1998)

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:

—

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 the Directive 98/34/EC of the European Parliament and of the Council (2) amended by the 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.

—	This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

More information about harmonised standards on the Internet at:

http://ec.europa.eu/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.cen.eu)

—	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).

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

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

23.7.2008

Official Journal of the European Union

C 186/25

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

(Text with EEA relevance)

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

(2008/C 186/08)

ESO (1)	Reference and title of the harmonised standard (and reference document)	Reference of superseded standard	Date of cessation of presumption of conformity of superseded standard (Note 1)
CEN	EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use	—
CEN	EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing	—
CEN	EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices	EN 556:1994 + A1:1998	Date expired (30.4.2002)
CEN	EN 556-1:2001/AC:2006
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 980:2008 Symbols for use in the labelling of medical devices	EN 980:2003	31.5.2010
CEN	EN 12286:1998 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures	—
CEN	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	—
CEN	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 46003:1999 EN ISO 13485:2000 EN ISO 13488:2000	31.7.2009
CEN	EN ISO 13485:2003/AC:2007
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 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures	—
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 14971:2007 Medical devices — Application of risk management to medical devices (ISO 14971:2007)	EN ISO 14971:2000	31.3.2010
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)	—
CEN	EN ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)	—

Note 1

Note 3

Note:

—

—	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.

—	This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

More information about harmonised standards on the Internet at:

http://ec.europa.eu/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.cen.eu)

—	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).

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

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

23.7.2008

Official Journal of the European Union

C 186/28

Commission communication in the framework of the implementation of the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices

(Text with EEA relevance)

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

(2008/C 186/09)

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 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 + A1:1998	Date expired (30.4.2002)
CEN	EN 556-1:2001/AC:2006
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 980:2008 Symbols for use in the labelling of medical devices	EN 980:2003	31.5.2010
CEN	EN 1041:1998 Information supplied by the manufacturer with medical devices	—
CEN	EN ISO 10993-1:2003 Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)	—
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 10993-4:2002/A1:2006	Note 3	Date expired (31.1.2007)
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 10993-6:2007 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007)	EN 30993-6:1994	Date expired (31.10.2007)
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 10993-10:2002/A1:2006	Note 3	Date expired (31.1.2007)
CEN	EN ISO 10993-11:2006 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)	EN ISO 10993-11:1995	Date expired (28.2.2007)
CEN	EN ISO 10993-12:2007 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007)	EN ISO 10993-12:2004	Date expired (31.5.2008)
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 10993-16:1997 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 10993-18:2005 Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)	—
CEN	EN ISO 11135-1:2007 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)	EN 550:1994	31.5.2010
CEN	EN ISO 11137-1:2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)	EN 552:1994	30.4.2009
CEN	EN ISO 11137-2:2007 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 1.8.2006)	—
CEN	EN ISO 11138-2:2006 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)	—
CEN	EN ISO 11138-3:2006 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)	—
CEN	EN ISO 11140-1:2005 Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)	—
CEN	EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)	EN 868-1:1997	Date expired (30.4.2007)
CEN	EN ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)	EN 1174-1:1996 EN 1174-2:1996 EN 1174-3:1996	Date expired (31.10.2006)
CEN	EN ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)	EN 46003:1999 EN ISO 13485:2000 EN ISO 13488:2000	31.7.2009
CEN	EN ISO 13485:2003/AC:2007
CEN	EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements	—
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 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 14971:2007 Medical devices — Application of risk management to medical devices (ISO 14971:2007)	EN ISO 14971:2000	31.3.2010
CEN	EN ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)	EN 554:1994	31.8.2009
CEN	EN 45502-1:1997 Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer	—
CEN	EN 45502-2-1:2004 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)	—

Note 1

Note 3

Note:

—

—	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.

—	This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

More information about harmonised standards on the Internet at:

http://ec.europa.eu/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.cen.eu)

—	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).

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

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

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

23.7.2008

Official Journal of the European Union

C 186/32

Notice of initiation of an anti-dumping proceeding concerning imports of sodium metal originating in the United States of America

(2008/C 186/10)

The Commission has received a complaint pursuant to Article 5 of Council Regulation (EC) No 384/96 of 22 December 1995 on protection against dumped imports from countries not members of the European Community (1) (‘the basic Regulation’), alleging that imports of sodium metal, originating in the United States of America (‘the country concerned’), are being dumped and are thereby causing material injury to the Community industry.

1. Complaint

The complaint was lodged on 10 June 2008 by the sole Community producer Métaux Spéciaux (‘MSSA SAS’) (‘the complainant’).

2. Product

The product allegedly being dumped is sodium, in bulk, originating in the United States of America (‘the product concerned’), normally declared within CN code ex 2805 11 00. This CN code is only given for information.

3. Allegation of dumping

The allegation of dumping in respect of the United States of America is based on a comparison of normal value established on the basis of domestic prices, with the export prices of the product concerned when sold for export to the Community.

On this basis, the dumping margin calculated is significant.

4. Allegation of injury

The complainant has provided evidence that imports of the product concerned from the United States of America have increased overall in absolute terms and in terms of market share.

It is alleged that the volumes and the prices of the imported product concerned have, among other consequences, had a negative impact on the market share held and the level of prices charged by the Community industry, resulting in substantial adverse effects on the overall performance, the financial situation and the employment situation of the Community industry.

5. Procedure

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

5.1. Procedure for the determination of dumping and injury

The investigation will determine whether the product concerned originating in the United States of America is being dumped and whether this dumping has caused injury.

(a) Questionnaires

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the Community industry and to any association of producers in the Community, to the exporters/producers in the United States of America, to any association of exporters/producers, to the importers, to any known association of importers, and to the authorities of the exporting country concerned.

(b) Collection of information and holding of hearings

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

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

5.2. Procedure for assessment of Community interest

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

6. Time limits

(a) For parties to request a questionnaire

All interested parties should request a questionnaire, as soon as possible, but not later than 15 days after the publication of this notice in the Official Journal of the European Union.

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

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

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

7. Written submissions, questionnaire replies and correspondence

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

Commission address for correspondence:

European Commission

Directorate-General for Trade

Directorate H

Office: J-79 4/23

B-1049 Brussels

Fax (32-2) 295 65 05

8. Non-cooperation

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

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

9. Schedule of the investigation

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

10. Processing of personal data

It is noted that any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (3).

11. Hearing Officer

It is also noted that if interested parties consider that they are encountering difficulties in the exercise of their rights of defence, they may request the intervention of the Hearing Officer of DG Trade. He acts as an interface between the interested parties and the Commission services, offering, where necessary, mediation on procedural matters affecting the protection of their interests in this proceeding, in particular, with regard to issues concerning access to file, confidentiality, extension of time limits and the treatment of written and/or oral submission of views. For further information and contact details interested parties may consult the Hearing Officer's web pages of the website of DG Trade (http://ec.europa.eu/trade).

(1) OJ L 56, 6.3.1996, p. 1. Regulation as last amended by Regulation (EC) No 2117/2005 (OJ L 340, 23.12.2005, p. 17).

(2) This means that the document is for internal use only. It is protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). It is a confidential document pursuant to Article 19 of the basic Regulation and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-dumping Agreement).

(3) OJ L 8, 12.1.2001, p. 1.

23.7.2008

Official Journal of the European Union

C 186/35

Notice of initiation of an anti-subsidy proceeding concerning imports of sodium metal originating in the United States of America

(2008/C 186/11)

The Commission has received a complaint pursuant to Article 10 of Council Regulation (EC) No 2026/97 on protection against subsidised imports from countries not members of the European Community (1) (‘the basic Regulation’), alleging that imports of sodium metal, originating in the United States of America (‘the country concerned’), are being subsidised and are thereby causing material injury to the Community industry.

1. Complaint

The complaint was lodged on 10 June 2008 by the sole Community producer Métaux Spéciaux (MSSA SAS) (‘the complainant’).

2. Product

The product allegedly being subsidised is sodium, in bulk, originating in the United States of America (‘the product concerned’), normally declared within CN code ex 2805 11 00. This CN code is only given for information.

3. Allegation of subsidisation

It is alleged that the producers of the product concerned from the United States of America have benefited from a number of State subsidies granted by the Government of the State of New York. The subsidies consist of allocations in the framework of the New York State Power Programs for Economic Development: ‘Replacement Power’ and ‘Expansion Power’.

It is alleged that the above schemes are subsidies since they involve a financial contribution from the Government of the United States of America or other state Governments and confer a benefit to the recipients, i.e. to exporters/producers of sodium metal. They are alleged to be limited to specific companies and therefore specific and countervailable.

4. Allegation of injury

The complainant has provided evidence that imports of the product concerned from the United States of America have increased overall in absolute terms and in terms of market share.

5. Procedure

5.1. Procedure for the determination of subsidisation and injury

The investigation will determine whether the product concerned originating in the United States of America is being subsidised and whether this subsidisation has caused injury.

(a) Questionnaires

(b) Collection of information and holding of hearings

5.2. Procedure for assessment of Community interest

In accordance with Article 31 of the basic Regulation and in the event that the allegations of subsidisation and injury caused thereby are substantiated, a decision will be reached as to whether the adoption of countervailing measures would not be against the Community interest. For this reason the Commission may send questionnaires to the known Community industry, importers, their representative associations, representative users and representative consumer organisations. Such parties, including those not known to the Commission, provided that they prove that there is an objective link between their activity and the product concerned, may, within the time limits set in point 6(b), make themselves known and provide the Commission with information. The parties which have acted in conformity with the preceding sentence may request a hearing setting the particular reasons why they should be heard within the time limit set in point 6(c). It should be noted that any information submitted pursuant to Article 31 of the basic Regulation will only be taken into account if supported by factual evidence at the time of submission.

6. Time limits

(a) For parties to request a questionnaire

All interested parties should request a questionnaire as soon as possible, but not later than 15 days after the publication of this notice in the Official Journal of the European Union.

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

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

7. Written submissions, questionnaire replies and correspondence

All submissions and requests made by interested parties must be made in writing (not in electronic format, unless otherwise specified) and must indicate the name, address, e-mail address, telephone and fax numbers of the interested party. All written submissions, including the information requested in this notice, questionnaire replies and correspondence provided by interested parties on a confidential basis shall be labelled as ‘Limited’ (2) and, in accordance with Article 29(2) of the basic Regulation, shall be accompanied by a non-confidential version, which will be labelled ‘For inspection by interested parties’.

Commission address for correspondence:

European Commission

Directorate-General for Trade

Directorate H

Office: J-79 4/23

B-1049 Brussels

Fax (32-2) 295 65 05

8. Non-cooperation

In cases in which any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made in accordance with Article 28 of the basic Regulation, on the basis of the facts available.

Where it is found that any interested party has supplied false or misleading information, the information shall be disregarded and use may be made of the facts available. If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 28 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

9. Schedule of the investigation

The investigation will be concluded, according to Article 11(9) of the basic Regulation within 13 months of the date of the publication of this notice in the Official Journal of the European Union. According to Article 12(1) of the basic Regulation, provisional measures may be imposed no later than 9 months from the publication of this notice in the Official Journal of the European Union.

10. Processing of personal data

It is noted that any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (3).

11. Hearing Officer

(1) OJ L 288, 21.10.1997, p. 1. Regulation as last amended by Regulation (EC) No 461/2004 (OJ L 77, 13.3.2004, p. 12).

(2) This means that the document is for internal use only. It is protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). It is a confidential document pursuant to Article 29 of the basic Regulation and Article 12 of the WTO Agreement on Subsidies and Countervailing Measures.

(3) OJ L 8, 12.1.2001, p. 1.

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

23.7.2008

Official Journal of the European Union

C 186/37

Prior notification of a concentration

(Case COMP/M.5201 — Total Produce/Haluco/JV)

(Text with EEA relevance)

(2008/C 186/12)

On 4 July 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Total Produce plc (‘Total Produce’, Ireland) and Haluco Beheer BV (‘Haluco’, the Netherlands) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertakings TP Haluco Holding BV (‘TP Haluco’, the Netherlands) and Total Produce will acquire sole control of Haluco UK Ltd (‘Haluco UK’, United Kingdom) by way of purchase of shares.

The business activities of the undertakings concerned are:

—	for undertaking Total Produce: procurement, importation, marketing and distribution of fruit and vegetables, pot plants and household items,

—	for undertaking Haluco: procurement, importation, marketing and distribution of fresh products,

—	for undertaking TP Haluco: procurement, importation, marketing and distribution of fresh products,

—	for undertaking Haluco UK: wholesale distribution of fresh products.

3.	On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5201 — Total Produce/Haluco/JV to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

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

23.7.2008

Official Journal of the European Union

C 186/38

Prior notification of a concentration

(Case COMP/M.5155 — Mondi/Loparex Assets)

(Text with EEA relevance)

(2008/C 186/13)

On 14 July 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertaking Mondi Coating BV (The Netherlands) controlled by Mondi plc (‘Mondi’, United Kingdom) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of parts of the undertaking Loparex Holding BV (‘Loparex Assets’, The Netherlands) by way of purchase of assets.

The business activities of the undertakings concerned are:

—	for Mondi: manufacture of packaging paper, converted packaging products and uncoated fine paper as well as merchant operations and newsprint operations,

—	for Loparex Assets: manufacture of release liners, kraft paper and extrusion coating products.

3.	On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5155 — Mondi/Loparex Assets, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

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

23.7.2008

Official Journal of the European Union

C 186/39

Prior notification of a concentration

(Case COMP/M.5268 — Goldman Sachs/PAI/Xella International)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 186/14)

On 15 July 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which The Goldman Sachs Group Inc. (‘Goldman Sachs’, USA) and PAI Partners SAS (‘PAI’, France) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of Xella International GmbH (‘Xella’, Germany) by way of purchase of shares

The business activities of the undertakings concerned are:

—	for Goldman Sachs: global investment banking, financial services,

—	for PAI: private equity,

—	for Xella: building materials for walls, limestone products.

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

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5268 — Goldman Sachs/PAI/Xella International, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

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

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

23.7.2008

Official Journal of the European Union

C 186/40

Prior notification of a concentration

(Case COMP/M.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 186/15)

On 3 July 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Zurich Vida, Compañía de Seguros y Reaseguros, SA (‘Zurich Vida’, Spain) and Zurich España, Compañía de Seguros y Reaseguros, SA (‘Zurich Generales’, Spain) belonging to the Zurich Group (‘Zurich Group’, Switzerland) and Caixa d'Estalvis de Sabadell (‘Caixa Sabadell’, Spain) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of CaixaSabadell Vida, SA de Seguros y Reaseguros (‘Sabadell Vida’, Spain) and CaixaSabadell Compañía d'Assegurances Generals, SA (‘Sabadell Generales’, Spain), which are currently wholly-owned subsidiaries of Caixa Sabadell, by way of purchase of shares.

The business activities of the undertakings concerned are:

—	for Zurich Group: insurance, re-insurance, pensions and investment products in Europe, America and Asia,

—	for Zurich Vida: Spanish subsidiary of the Zurich Group in the field of life insurance,

—	for Zurich Generales: Spanish subsidiary of the Zurich Group in the field of non-life insurance,

—	for Caixa Sabadell: savings bank mainly active in retail banking,

—	for Sabadell Vida: life insurance and pension products,

—	for Sabadell Generales: non-life insurance (home and accidents insurance).

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5242 — Zurich/Caixa Sabadell/Sabadell Vida/Sabadell Generales, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

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

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

Corrigenda

23.7.2008

Official Journal of the European Union

C 186/41

Corrigendum to notice for the attention of the persons, groups and entities on the list provided for in Article 2(3) of Council Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism

( Official Journal of the European Union C 179 of 16 July 2008 )

(2008/C 186/16)

On page 1, in the first paragraph:

for:

‘Council Decision 2008/584/EC’,

read:

‘Council Decision 2008/583/EC’.

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