# Official Journal C 267/2007

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 267 |
| | |
| English edition | Information and Notices | Volume 509 November 2007 |

ISSN 1725-2423

Official Journal

of the European Union

C 267

English edition

Information and Notices

Volume 509 November 2007

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2007/C 267/01 | Non-opposition to a notified concentration (Case COMP/M.4850 — CVC/DSI) (
  1
  ) | 1 |
| 2007/C 267/02 | Non-opposition to a notified concentration (Case COMP/M.4837 — Wallenius/Antelo/GAL/CAT) (
  1
  ) | 1 |
| 2007/C 267/03 | Non-opposition to a notified concentration (Case COMP/M.4918 — Carlyle/Applus) (
  1
  ) | 2 |
| 2007/C 267/04 | Non-opposition to a notified concentration (Case COMP/M.4849 — 21 Centrale Partners/Nord Est) (
  1
  ) | 2 |
| 2007/C 267/05 | Non-opposition to a notified concentration (Case COMP/M.4789 — ELG Haniel/Metal One/JV) (
  1
  ) | 3 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2007/C 267/01

Non-opposition to a notified concentration (Case COMP/M.4850 — CVC/DSI) (
  1
  )

1

1

2007/C 267/02

Non-opposition to a notified concentration (Case COMP/M.4837 — Wallenius/Antelo/GAL/CAT) (
  1
  )

1

1

2007/C 267/03

Non-opposition to a notified concentration (Case COMP/M.4918 — Carlyle/Applus) (
  1
  )

1

2

2007/C 267/04

Non-opposition to a notified concentration (Case COMP/M.4849 — 21 Centrale Partners/Nord Est) (
  1
  )

1

2

2007/C 267/05

Non-opposition to a notified concentration (Case COMP/M.4789 — ELG Haniel/Metal One/JV) (
  1
  )

1

3

| | III   Preparatory Acts |
| --- | --- |
| | MEMBER STATES' INITIATIVES |
| | Council |
| 2007/C 267/06 | Initiative of the Federal Republic of Germany with a view to the adoption of a Council Decision 2007/.../JHA of ... on the implementation of Decision 2007/.../JHA on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime | 4 |

III   Preparatory Acts

MEMBER STATES' INITIATIVES

Council

2007/C 267/06

Initiative of the Federal Republic of Germany with a view to the adoption of a Council Decision 2007/.../JHA of ... on the implementation of Decision 2007/.../JHA on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime

4

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2007/C 267/07 | Euro exchange rates | 9 |
| | NOTICES FROM MEMBER STATES |
| 2007/C 267/08 | Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (
  1
  ) | 10 |
| 2007/C 267/09 | 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 |
| 2007/C 267/10 | 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 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2007/C 267/07

Euro exchange rates

9

NOTICES FROM MEMBER STATES

2007/C 267/08

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

1

10

2007/C 267/09

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
  )

in vitro

1

25

2007/C 267/10

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
  )

1

28

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY |
| | Commission |
| 2007/C 267/11 | Notice of initiation of an anti-dumping proceeding concerning imports of certain iron or steel fasteners originating in the People's Republic of China | 31 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2007/C 267/12 | Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the Nogent-sur-Seine Licence)
   (
  1
  ) | 36 |
| 2007/C 267/13 | Prior notification of a concentration (Case COMP/M.4803 — RBS/Sempra) — Candidate case for simplified procedure (
  1
  ) | 38 |
| 2007/C 267/14 | Prior notification of a concentration (Case COMP/M.4513 — Arjowiggins/M-real Zanders Reflex) (
  1
  ) | 39 |
| | OTHER ACTS |
| | Commission |
| 2007/C 267/15 | Publication of an application pursuant to Article 8(2) of Council Regulation (EC) No 509/2006 on agricultural products and foodstuffs as traditional specialities guaranteed | 40 |
| 2007/C 267/16 | Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs | 46 |
| 2007/C 267/17 | Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs | 50 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

2007/C 267/11

Notice of initiation of an anti-dumping proceeding concerning imports of certain iron or steel fasteners originating in the People's Republic of China

31

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2007/C 267/12

Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the Nogent-sur-Seine Licence)
   (
  1
  )

(Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the Nogent-sur-Seine Licence)

1

36

2007/C 267/13

Prior notification of a concentration (Case COMP/M.4803 — RBS/Sempra) — Candidate case for simplified procedure (
  1
  )

1

38

2007/C 267/14

Prior notification of a concentration (Case COMP/M.4513 — Arjowiggins/M-real Zanders Reflex) (
  1
  )

1

39

OTHER ACTS

Commission

2007/C 267/15

Publication of an application pursuant to Article 8(2) of Council Regulation (EC) No 509/2006 on agricultural products and foodstuffs as traditional specialities guaranteed

40

2007/C 267/16

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

46

2007/C 267/17

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

50

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

---

(1)   Text with EEA relevance

1

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

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 9.11.2007 | EN | Official Journal of the European Union | C 267/1 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/1

---

Non-opposition to a notified concentration

(Case COMP/M.4850 — CVC/DSI)

(Text with EEA relevance)

(2007/C 267/01)

On 25 September 2007, 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, |
| --- | --- |

—

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 32007M4850. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32007M4850. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 9.11.2007 | EN | Official Journal of the European Union | C 267/1 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/1

---

Non-opposition to a notified concentration

(Case COMP/M.4837 — Wallenius/Antelo/GAL/CAT)

(Text with EEA relevance)

(2007/C 267/02)

On 5 September 2007, 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, |
| --- | --- |

—

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 32007M4837. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32007M4837. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 9.11.2007 | EN | Official Journal of the European Union | C 267/2 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/2

---

Non-opposition to a notified concentration

(Case COMP/M.4918 — Carlyle/Applus)

(Text with EEA relevance)

(2007/C 267/03)

On 30 October 2007, 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, |
| --- | --- |

—

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 32007M4918. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32007M4918. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 9.11.2007 | EN | Official Journal of the European Union | C 267/2 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/2

---

Non-opposition to a notified concentration

(Case COMP/M.4849 — 21 Centrale Partners/Nord Est)

(Text with EEA relevance)

(2007/C 267/04)

On 19 October 2007, 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, |
| --- | --- |

—

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 32007M4849. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32007M4849. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

| 9.11.2007 | EN | Official Journal of the European Union | C 267/3 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/3

---

Non-opposition to a notified concentration

(Case COMP/M.4789 — ELG Haniel/Metal One/JV)

(Text with EEA relevance)

(2007/C 267/05)

On 27 September 2007, 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, |
| --- | --- |

—

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 32007M4789. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32007M4789. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

III Preparatory Acts

MEMBER STATES' INITIATIVES

Council

| 9.11.2007 | EN | Official Journal of the European Union | C 267/4 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/4

---

Initiative of the Federal Republic of Germany with a view to the adoption of a Council Decision 2007/.../JHA of ... on the implementation of Decision 2007/.../JHA on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime

(2007/C 267/06)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 30(1)(a) and (b), Article 31(1)(a), Article 32 and the second sentence of Article 34(2)(c) thereof,

Having regard to Article 33 of Decision 2007/.../JHA (1),

Having regard to the initiative of the Federal Republic of Germany,

Having regard to the Opinion of the European Parliament,

Whereas:

| (1) | On ... 2007 the Council adopted Decision 2007/.../JHA. |
| --- | --- |

(1)

On ... 2007 the Council adopted Decision 2007/.../JHA.

| (2) | By means of Decision 2007/.../JHA, the basic elements of the Treaty of 27 May 2005 between the Kingdom of Belgium, the Federal Republic of Germany, the Kingdom of Spain, the French Republic, the Grand Duchy of Luxembourg, the Kingdom of the Netherlands and the Republic of Austria on the stepping up of cross-border cooperation, particularly in combating terrorism, cross-border crime and illegal migration (hereinafter ‘the Prüm Treaty’), were transposed into the legal framework of the European Union. |
| --- | --- |

(2)

By means of Decision 2007/.../JHA, the basic elements of the Treaty of 27 May 2005 between the Kingdom of Belgium, the Federal Republic of Germany, the Kingdom of Spain, the French Republic, the Grand Duchy of Luxembourg, the Kingdom of the Netherlands and the Republic of Austria on the stepping up of cross-border cooperation, particularly in combating terrorism, cross-border crime and illegal migration (hereinafter ‘the Prüm Treaty’), were transposed into the legal framework of the European Union.

| (3) | Article 33 of Decision 2007/.../JHA provides that the Council is to adopt the measures necessary to implement Decision 2007/.../JHA at the level of the Union in accordance with the procedure laid down in the second sentence of Article 34(2)(c) of the Treaty. These measures are to be based on the Implementing Agreement of 5 December 2006 concerning the administrative and technical implementation and application of the Prüm Treaty. |
| --- | --- |

(3)

Article 33 of Decision 2007/.../JHA provides that the Council is to adopt the measures necessary to implement Decision 2007/.../JHA at the level of the Union in accordance with the procedure laid down in the second sentence of Article 34(2)(c) of the Treaty. These measures are to be based on the Implementing Agreement of 5 December 2006 concerning the administrative and technical implementation and application of the Prüm Treaty.

| (4) | This Decision establishes those common normative provisions which are indispensable for administrative and technical implementation of the forms of cooperation set out in Decision 2007/.../JHA. The Annex contains implementing provisions of a technical nature. Furthermore, a separate Manual, containing exclusively factual information to be provided by the Member States, will be drawn up and kept up to date by the General Secretariat of the Council, |
| --- | --- |

(4)

This Decision establishes those common normative provisions which are indispensable for administrative and technical implementation of the forms of cooperation set out in Decision 2007/.../JHA. The Annex contains implementing provisions of a technical nature. Furthermore, a separate Manual, containing exclusively factual information to be provided by the Member States, will be drawn up and kept up to date by the General Secretariat of the Council,

HAS DECIDED AS FOLLOWS:

CHAPTER I

GENERAL

Article 1

Aim

The aim of this Decision is to lay down the necessary administrative and technical provisions for the implementation of Decision 2007/.../JHA, especially for the automated exchange of DNA data, dactyloscopic data and vehicle registration data as set out in Chapter II thereof as well as other forms of cooperation as set out in Chapter V thereof.

Article 2

Definitions

For the purposes of this Decision:

| (a) | ‘search’ and ‘comparison’ as referred to in Articles 3, 4 and 9 of Decision 2007/.../JHA mean the procedures by which it is established whether there is a match between, respectively, DNA data or dactyloscopic data which have been communicated by one Member State and DNA data or dactyloscopic data stored in the databases of one, several, or all of the Member States; |
| --- | --- |

(a)

‘search’ and ‘comparison’ as referred to in Articles 3, 4 and 9 of Decision 2007/.../JHA mean the procedures by which it is established whether there is a match between, respectively, DNA data or dactyloscopic data which have been communicated by one Member State and DNA data or dactyloscopic data stored in the databases of one, several, or all of the Member States;

| (b) | ‘automated searching’ as referred to in Article 12 of Decision 2007/.../JHA means an online access procedure for consulting the databases of one, several, or all of the Member States; |
| --- | --- |

(b)

‘automated searching’ as referred to in Article 12 of Decision 2007/.../JHA means an online access procedure for consulting the databases of one, several, or all of the Member States;

| (c) | ‘DNA reference data’ means a DNA profile and a reference number; |
| --- | --- |

(c)

‘DNA reference data’ means a DNA profile and a reference number;

| (d) | ‘DNA profile’ means a letter or a number code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci); |
| --- | --- |

(d)

‘DNA profile’ means a letter or a number code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci);

| (e) | ‘non-coding part of DNA’ means chromosome regions not genetically expressed, i.e. not known to provide for any functional properties of an organism; |
| --- | --- |

(e)

‘non-coding part of DNA’ means chromosome regions not genetically expressed, i.e. not known to provide for any functional properties of an organism;

| (f) | ‘reference DNA profile’ means the DNA profile of an identified person; |
| --- | --- |

(f)

‘reference DNA profile’ means the DNA profile of an identified person;

| (g) | ‘unidentified DNA profile’ means the DNA profile obtained from traces collected during the investigation of criminal offences and belonging to a person not yet identified; |
| --- | --- |

(g)

‘unidentified DNA profile’ means the DNA profile obtained from traces collected during the investigation of criminal offences and belonging to a person not yet identified;

| (h) | ‘note’ means a Member State's marking on a DNA profile in its national database indicating that there has already been a match for that DNA profile on another Member State's search or comparison; |
| --- | --- |

(h)

‘note’ means a Member State's marking on a DNA profile in its national database indicating that there has already been a match for that DNA profile on another Member State's search or comparison;

| (i) | ‘dactyloscopic data’ means fingerprint images, images of fingerprint latents, palm prints, palm print latents as well as templates of such images (coded minutiae), when they are stored and dealt with in an automated database; |
| --- | --- |

(i)

‘dactyloscopic data’ means fingerprint images, images of fingerprint latents, palm prints, palm print latents as well as templates of such images (coded minutiae), when they are stored and dealt with in an automated database;

| (j) | ‘vehicle registration data’ means the data-set as specified in Chapter III of the Annex to this Decision; |
| --- | --- |

(j)

‘vehicle registration data’ means the data-set as specified in Chapter III of the Annex to this Decision;

| (k) | ‘individual case’, as referred to in Article 3(1), second sentence, Article 9(1), second sentence and Article 12(1), second sentence, of Decision 2007/.../JHA, means a single investigation or prosecution file. If such a file contains more than one DNA profile, or one piece of dactyloscopic data or vehicle registration data, they may be transmitted together as one request. |
| --- | --- |

(k)

‘individual case’, as referred to in Article 3(1), second sentence, Article 9(1), second sentence and Article 12(1), second sentence, of Decision 2007/.../JHA, means a single investigation or prosecution file. If such a file contains more than one DNA profile, or one piece of dactyloscopic data or vehicle registration data, they may be transmitted together as one request.

CHAPTER II

COMMON PROVISIONS FOR DATA EXCHANGE

Article 3

Technical specifications

Member States shall observe the common technical specifications in connection with all requests and answers related to searches and comparisons of DNA profiles, dactyloscopic data and vehicle registration data. These technical specifications are laid down in the Annex to this Decision.

Article 4

Communications network

The electronic exchange of DNA data, dactyloscopic data and vehicle registration data between Member States shall take place using the Trans European Services for Telematics between Administrations (TESTA II) communications network and further developments thereof.

Article 5

Availability of automated data exchange

Member States shall take all necessary measures to ensure that automated searching or comparison of DNA data, dactyloscopic data and vehicle registration data is possible 24 hours a day and seven days a week. In the event of a technical fault, the Member States' national contact points shall immediately inform each other and shall agree on temporary alternative information exchange arrangements in accordance with the legal provisions applicable. Automated data exchange shall be re-established as quickly as possible.

Article 6

Reference numbers for DNA data and dactyloscopic data

The reference numbers referred to in Article 2 and Article 8 of Decision 2007/.../JHA shall consist of a combination of the following:

| 1. | a code allowing the Member States, in the case of a match, to retrieve personal data and other information in their databases in order to supply it to one, several or all of the Member States in accordance with Article 5 or Article 10 of Decision 2007/.../JHA; |
| --- | --- |

1.

a code allowing the Member States, in the case of a match, to retrieve personal data and other information in their databases in order to supply it to one, several or all of the Member States in accordance with Article 5 or Article 10 of Decision 2007/.../JHA;

| 2. | a code to indicate the national origin of the DNA profile or dactyloscopic data; and |
| --- | --- |

2.

a code to indicate the national origin of the DNA profile or dactyloscopic data; and

| 3. | with respect to DNA data, a code to indicate the type of DNA profile. |
| --- | --- |

3.

with respect to DNA data, a code to indicate the type of DNA profile.

CHAPTER III

DNA DATA

Article 7

Principles of DNA data exchange

1.   Member States shall use existing standards for DNA data exchange, such as the European Standard Set (ESS) or the Interpol Standard Set of Loci (ISSOL).

2.   The transmission procedure, in the case of automated searching and comparison of DNA profiles, shall take place within a decentralised structure.

3.   Appropriate measures shall be taken to ensure confidentiality and integrity for data being sent to other Member States, including their encryption.

4.   Member States shall take the necessary measures to guarantee the integrity of the DNA profiles made available or sent for comparison to the other Member States and to ensure that these measures comply with international standards such as ISO 17025.

5.   Member States shall use Member State codes in accordance with the ISO 3166-1 alpha-2 standard.

Article 8

Rules for requests and answers in connection with DNA data

1.   A request for an automated search or comparison, as referred to in Articles 3 or 4 of Decision 2007/.../JHA, shall include only the following information:

| (a) | the Member State code of the requesting Member State; |
| --- | --- |

(a)

the Member State code of the requesting Member State;

| (b) | the date, time and indication number of the request; |
| --- | --- |

(b)

the date, time and indication number of the request;

| (c) | DNA profiles and their reference numbers; |
| --- | --- |

(c)

DNA profiles and their reference numbers;

| (d) | the types of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles); |
| --- | --- |

(d)

the types of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles);

| (e) | information required for controlling the database systems and quality control for the automatic search processes. |
| --- | --- |

(e)

information required for controlling the database systems and quality control for the automatic search processes.

2.   The answer (matching report) to the request referred to in paragraph 1 shall contain only the following information:

| (a) | an indication as to whether there were one or more matches (hits) or no matches (no hits); |
| --- | --- |

(a)

an indication as to whether there were one or more matches (hits) or no matches (no hits);

| (b) | the date, time and indication number of the request; |
| --- | --- |

(b)

the date, time and indication number of the request;

| (c) | the date, time and indication number of the answer; |
| --- | --- |

(c)

the date, time and indication number of the answer;

| (d) | the Member State codes of the requesting and requested Member States; |
| --- | --- |

(d)

the Member State codes of the requesting and requested Member States;

| (e) | the reference numbers of the requesting and requested Member States; |
| --- | --- |

(e)

the reference numbers of the requesting and requested Member States;

| (f) | the type of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles); |
| --- | --- |

(f)

the type of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles);

| (g) | the requested and matching DNA profiles; and |
| --- | --- |

(g)

the requested and matching DNA profiles; and

| (h) | information required for controlling the database systems and quality control for the automatic search processes. |
| --- | --- |

(h)

information required for controlling the database systems and quality control for the automatic search processes.

3.   Automated notification of a match shall only be provided if the automated search or comparison has resulted in a match of a minimum number of loci. This minimum is set out in Chapter I of the Annex to this Decision.

4.   The Member States shall ensure that requests comply with the declarations issued in accordance with Article 2(3) of Decision 2007/.../JHA. These declarations shall be reproduced in the Manual referred to in Article 18(2) of this Decision.

Article 9

Transmission procedure for automated search of unidentified DNA profiles in accordance with Article 3 of Decision 2007/.../JHA

1.   If, in a search with an unidentified DNA profile, no match has been found in the national database, or a match has been found with an unidentified DNA profile, the unidentified DNA profile may then be transmitted to all other Member States' databases and if, in a search with this unidentified DNA profile, matches are found with reference DNA profiles and/or unidentified DNA profiles in other Member States' databases, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting Member State; if no matches can be found in other Member States' databases, this shall be automatically communicated to the requesting Member State.

2.   If, in a search with an unidentified DNA profile, a match is found in other Member States' databases, each Member State concerned may insert a note to this effect in its national database.

Article 10

Transmission procedure for automated search of reference DNA profiles in accordance with Article 3 of Decision 2007/.../JHA

If, in a search with a reference DNA profile, no match has been found in the national database with a reference DNA profile or a match has been found with an unidentified DNA profile, this reference DNA profile may then be transmitted to all other Member States' databases and if, in a search with this reference DNA profile, matches are found with reference DNA profiles and/or unidentified DNA profiles in other Member States' databases, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting Member State; if no matches can be found in other Member States' databases, it shall be automatically communicated to the requesting Member State.

Article 11

Transmission procedure for automated comparison of unidentified DNA profiles in accordance with Article 4 of Decision 2007/.../JHA

1.   If, in a comparison with unidentified DNA profiles, matches are found in other Member States' databases with reference DNA profiles and/or unidentified DNA profiles, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting Member State.

2.   If, in a comparison with unidentified DNA profiles, matches are found in other Member States' databases with unidentified DNA profiles or reference DNA profiles, each Member State concerned may insert a note to this effect in its national database.

CHAPTER IV

DACTYLOSCOPIC DATA

Article 12

Principles for the exchange of dactyloscopic data

1.   The digitalisation of dactyloscopic data and their transmission to the other Member States shall be carried out in accordance with a uniform data format specified in Chapter II of the Annex to this Decision.

2.   Each Member State shall ensure that the dactyloscopic data it transmits are of sufficient quality for a comparison by the automated fingerprint identification systems (AFIS).

3.   The transmission procedure for the exchange of dactyloscopic data shall take place within a decentralised structure.

4.   Appropriate measures shall be taken to ensure the confidentiality and integrity of dactyloscopic data being sent to other Member States, including their encryption.

5.   The Member States shall use Member State codes in accordance with the ISO 3166-1 alpha-2 standard.

Article 13

Search capacities for dactyloscopic data

1.   Each Member State shall ensure that its search requests do not exceed the search capacities specified by the requested Member State. Member States shall submit declarations as referred to in Article 18(2) to the General Secretariat of the Council in which they lay down their maximum search capacities per day for dactyloscopic data of identified persons and for dactyloscopic data of persons not yet identified.

2.   The maximum numbers of candidates accepted for verification per transmission are set out in Chapter II of the Annex to this Decision.

Article 14

Rules for requests and answers in connection with dactyloscopic data

1.   The requested Member State shall check the quality of the transmitted dactyloscopic data without delay by a fully automated procedure. Should the data be unsuitable for an automated comparison, the requested Member State shall inform the requesting Member State without delay.

2.   The requested Member State shall conduct searches in the order in which requests are received. Requests shall be processed within 24 hours by a fully automated procedure. The requesting Member State may, if its national law so prescribes, ask for accelerated processing of its request and the requested Member State shall conduct the search without delay. If deadlines cannot be met for reasons of force majeure, the comparison shall be carried out without delay as soon as the impediments have been removed.

CHAPTER V

VEHICLE REGISTRATION DATA

Article 15

Principles of automated searching of vehicle registration data

1.   For automated searching of vehicle registration data Member States shall use a version of the European Vehicle and Driving Licence Information System (EUCARIS) software application especially designed for the purposes of Article 12 of Decision 2007/.../JHA, and amended versions of this software.

2.   Automated searching of vehicle registration data shall take place within a decentralised structure.

3.   The information exchanged via the EUCARIS system shall be transmitted in encrypted form.

4.   The data elements of the vehicle registration data to be exchanged are specified in Chapter III of the Annex to this Decision.

5.   In the implementation of Article 12 of Decision 2007/.../JHA, Member States may give priority to searches related to combating serious crime in the event of limited technical capacities.

Article 16

Costs

Member States shall bear the costs arising from the administration and use of the EUCARIS software application mentioned in Article 15(1).

CHAPTER VI

POLICE COOPERATION

Article 17

1.   In accordance with Chapter V of Decision 2007/.../JHA, and in particular with the declarations submitted pursuant to its Articles 17(4), 19(2), and 19(4), each Member State may specify its procedures for setting up joint operations, its procedures for incoming requests from other Member States with regard to those operations, as well as other practical aspects and operational modalities in relation to those operations.

2.   Member States may also designate appropriate contact points so as to allow other Member States to address the competent authorities where there is no specified procedure for setting up joint operations.

3.   A request to set up a joint operation may be made by the competent authorities of each Member State. Before the start of a specific operation, Member States shall make written or verbal arrangements that may cover details such as:

| (a) | the competent authorities of the Member States for the operation; |
| --- | --- |

(a)

the competent authorities of the Member States for the operation;

| (b) | the specific purpose of the operation; |
| --- | --- |

(b)

the specific purpose of the operation;

| (c) | the host Member State where the operation takes place; |
| --- | --- |

(c)

the host Member State where the operation takes place;

| (d) | the geographical area of the host Member State where the operation takes place; |
| --- | --- |

(d)

the geographical area of the host Member State where the operation takes place;

| (e) | the period covered by the operation; |
| --- | --- |

(e)

the period covered by the operation;

| (f) | the specific assistance to be provided by the seconding Member State(s) to the host Member State, including officers or other officials, material and financial elements; |
| --- | --- |

(f)

the specific assistance to be provided by the seconding Member State(s) to the host Member State, including officers or other officials, material and financial elements;

| (g) | the officers participating in the operation; |
| --- | --- |

(g)

the officers participating in the operation;

| (h) | the officer in charge of the operation; |
| --- | --- |

(h)

the officer in charge of the operation;

| (i) | the powers the officers and other officials of the seconding Member State(s) may exercise in the host Member State during the operation; |
| --- | --- |

(i)

the powers the officers and other officials of the seconding Member State(s) may exercise in the host Member State during the operation;

| (j) | the particular arms, ammunition and equipment the seconding officers may use during the operation in accordance with Decision 2007/.../JHA; |
| --- | --- |

(j)

the particular arms, ammunition and equipment the seconding officers may use during the operation in accordance with Decision 2007/.../JHA;

| (k) | the logistic modalities as regards transport, accommodation and security; |
| --- | --- |

(k)

the logistic modalities as regards transport, accommodation and security;

| (l) | the allocation of the costs of the joint operation if it differs from that provided in the first sentence of Article 34 of Decision 2007/.../JHA; |
| --- | --- |

(l)

the allocation of the costs of the joint operation if it differs from that provided in the first sentence of Article 34 of Decision 2007/.../JHA;

| (m) | any other possible elements required. |
| --- | --- |

(m)

any other possible elements required.

4.   The declarations, procedures and designations provided for in this Article shall be reproduced in the Manual referred to in Article 18(2).

CHAPTER VII

FINAL PROVISIONS

Article 18

Annex and Manual

1.   Further details concerning the technical and administrative implementation of Decision 2007/.../JHA are set out in the Annex to this Decision. The Annex may be modified by the Council, acting by a qualified majority.

2.   A Manual shall be prepared and kept up to date by the General Secretariat of the Council, comprising exclusively factual information provided by the Member States through declarations made pursuant to Decision 2007/.../JHA or this Decision or through notifications made to the General Secretariat of the Council. The Manual shall be in the form of a Council Document.

Article 19

Independent data protection authorities

Member States shall, in accordance with Article 18(2) of this Decision, inform the General Secretariat of the Council of the independent data protection authorities or the judicial authorities as referred to in Article 30(5) of Decision 2007/.../JHA.

Article 20

Preparation of decisions referred to in Article 25(2) of Decision 2007.../JHA

1.   The Council shall take a decision referred to in Article 25(2) of Decision 2007/.../JHA on the basis of an evaluation report which shall be based on a questionnaire as set out in Chapter IV of the Annex to this Decision.

2.   With respect to the automated data exchange in accordance with Chapter II of Decision 2007.../JHA, the evaluation report shall also be based on an evaluation visit and a pilot run that shall be carried out when the Member State concerned has informed the General Secretariat in accordance with the first sentence of Article 36(2) of Decision 2007/.../JHA.

3.   Further details of the procedure are set out in Chapter IV of the Annex to this Decision.

Article 21

Evaluation of the data exchange

1.   An evaluation of the administrative, technical and financial application of the data exchange pursuant to Chapter II of Decision 2007/.../JHA shall be carried out on an annual basis. The evaluation shall relate to those Member States already applying Decision 2007/.../JHA at the time of the evaluation and shall be carried out with respect to the data categories for which data exchange has started among the Member States concerned. The evaluation shall be based on reports of the respective Member States.

2.   Further details of the procedure are set out in Chapter IV of the Annex to this Decision.

Article 22

Relationship with the Implementing Agreement of the Prüm Treaty

For the Member States bound by the Prüm Treaty, the relevant provisions of this Decision and its Annex, once fully implemented, shall apply instead of the corresponding provisions contained in the Implementing Agreement of the Prüm Treaty. Any other provisions of the Implementing Agreement shall remain applicable between the contracting parties of the Prüm Treaty.

Article 23

Application

This Decision shall take effect twenty days following its publication in the Official Journal of the European Union.

Done at Brussels, on ...

For the Council

The President

---

(1)  OJ L ...

1

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 9.11.2007 | EN | Official Journal of the European Union | C 267/9 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/9

---

Euro exchange rates (1)

8 November 2007

(2007/C 267/07)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,4666 |
| JPY | Japanese yen | 165,90 |
| DKK | Danish krone | 7,4548 |
| GBP | Pound sterling | 0,69625 |
| SEK | Swedish krona | 9,2620 |
| CHF | Swiss franc | 1,6601 |
| ISK | Iceland króna | 87,00 |
| NOK | Norwegian krone | 7,7410 |
| BGN | Bulgarian lev | 1,9558 |
| CYP | Cyprus pound | 0,5842 |
| CZK | Czech koruna | 26,894 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 253,34 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7017 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 3,6370 |
| RON | Romanian leu | 3,4030 |
| SKK | Slovak koruna | 33,122 |
| TRY | Turkish lira | 1,7359 |
| AUD | Australian dollar | 1,5783 |
| CAD | Canadian dollar | 1,3629 |
| HKD | Hong Kong dollar | 11,3896 |
| NZD | New Zealand dollar | 1,8923 |
| SGD | Singapore dollar | 2,1117 |
| KRW | South Korean won | 1 332,70 |
| ZAR | South African rand | 9,5080 |
| CNY | Chinese yuan renminbi | 10,8832 |
| HRK | Croatian kuna | 7,3365 |
| IDR | Indonesian rupiah | 13 396,66 |
| MYR | Malaysian ringgit | 4,8845 |
| PHP | Philippine peso | 63,284 |
| RUB | Russian rouble | 35,8820 |
| THB | Thai baht | 46,271 |

Currency

Exchange rate

USD

US dollar

1,4666

JPY

Japanese yen

165,90

DKK

Danish krone

7,4548

GBP

Pound sterling

0,69625

SEK

Swedish krona

9,2620

CHF

Swiss franc

1,6601

ISK

Iceland króna

87,00

NOK

Norwegian krone

7,7410

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,5842

CZK

Czech koruna

26,894

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

253,34

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7017

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,6370

RON

Romanian leu

3,4030

SKK

Slovak koruna

33,122

TRY

Turkish lira

1,7359

AUD

Australian dollar

1,5783

CAD

Canadian dollar

1,3629

HKD

Hong Kong dollar

11,3896

NZD

New Zealand dollar

1,8923

SGD

Singapore dollar

2,1117

KRW

South Korean won

1 332,70

ZAR

South African rand

9,5080

CNY

Chinese yuan renminbi

10,8832

HRK

Croatian kuna

7,3365

IDR

Indonesian rupiah

13 396,66

MYR

Malaysian ringgit

4,8845

PHP

Philippine peso

63,284

RUB

Russian rouble

35,8820

THB

Thai baht

46,271

---

(1)

Source: reference exchange rate published by the ECB.

---

NOTICES FROM MEMBER STATES

| 9.11.2007 | EN | Official Journal of the European Union | C 267/10 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/10

---

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)

(2007/C 267/08)

| 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 285:2006
  Sterilization — Steam sterilizers — Large sterilizers | EN 285:1996 | 30.11.2008 |
| 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) |
| 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 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 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 | Date Expired
  (31.12.2005) |
| 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 | — | |
| 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 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 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 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 | — | |
| 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 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 | 29.2.2008 |
| 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 | 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) | — | |
| EN ISO 8835-4:2004/AC:2006 | | |
| CEN | EN ISO 8835-5:2004
  Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004) | — | |
| 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 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) |
| 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 | 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) |
| 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 10993-12:2004
  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 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 1174-2:1996
  EN 1174-1:1996
  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 | — | |
| 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 ISO 12870:2004
  Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004) | EN ISO 12870:1997 | Date Expired
  (28.2.2005) |
| 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 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 13485:2000
  EN ISO 13488:2000 | Date Expired
  (31.7.2006) |
| EN ISO 13485:2003/AC:2007 | EN 46003:1999 | 31.7.2009 |
| CEN | EN 13544-1:2007
  Respiratory therapy equipment — Part 1: Nebulizing systems and their components | EN 13544-1:2001 | 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 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 13795-3:2006
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels | — | |
| 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 14630:2005
  Non-active surgical implants — General requirements (ISO 14630:2005) | EN ISO 14630:1997 | Date Expired
  (30.11.2005) |
| 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) | — | |
| 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 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 16201:2006
  Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006) | — | |
| 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 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 | 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) | — | |
| 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 | 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 | 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 | 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 ISO 11196:1997
  EN 864:1996 | Date Expired
  (31.5.2005) |
| 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 | 31.12.2007 |
| 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 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 | 31.1.2008 |
| 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) |

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 285:2006

Sterilization — Steam sterilizers — Large sterilizers

EN 285:1996

30.11.2008

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)

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 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 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

Date Expired

(31.12.2005)

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

—

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 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 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 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

—

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 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

29.2.2008

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

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)

—

EN ISO 8835-4:2004/AC:2006

CEN

EN ISO 8835-5:2004

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

—

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 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)

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

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)

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 10993-12:2004

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 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 1174-2:1996

EN 1174-1:1996

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

—

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 ISO 12870:2004

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

EN ISO 12870:1997

Date Expired

(28.2.2005)

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 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 13485:2000

EN ISO 13488:2000

Date Expired

(31.7.2006)

EN ISO 13485:2003/AC:2007

EN 46003:1999

31.7.2009

CEN

EN 13544-1:2007

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

EN 13544-1:2001

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 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 13795-3:2006

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels

—

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 14630:2005

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

EN ISO 14630:1997

Date Expired

(30.11.2005)

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)

—

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 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 16201:2006

Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006)

—

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 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

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)

—

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

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

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

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 ISO 11196:1997

EN 864:1996

Date Expired

(31.5.2005)

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

31.12.2007

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 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

31.1.2008

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)

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

—

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. |
| --- | --- |

—

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) |
| --- | --- |

—

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) |
| --- | --- |

—

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.

---

| 9.11.2007 | EN | Official Journal of the European Union | C 267/25 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/25

---

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)

(2007/C 267/09)

| 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 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) |
| 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 980:2003
  Graphical symbols for use in the labelling of medical devices | EN 980:1996 | Date Expired
  (31.10.2003) |
| 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 13485:2000
  EN ISO 13488:2000 | Date Expired
  (31.7.2006) |
| 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) | — | |

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)

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 980:2003

Graphical symbols for use in the labelling of medical devices

EN 980:1996

Date Expired

(31.10.2003)

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 13485:2000

EN ISO 13488:2000

Date Expired

(31.7.2006)

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

—

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. |
| --- | --- |

—

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) |
| --- | --- |

—

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) |
| --- | --- |

—

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.

---

| 9.11.2007 | EN | Official Journal of the European Union | C 267/28 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/28

---

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)

(2007/C 267/10)

| 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) |
| 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 980:2003
  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 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) |
| 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 | 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) |
| 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 10993-12:2004
  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 10993-16:1997
  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 1174-3:1996
  EN 1174-2:1996 | Date Expired
  (31.10.2006) |
| 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 | Date Expired
  (31.7.2006) |
| 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 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) | — | |

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)

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 980:2003

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 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)

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

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)

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 10993-12:2004

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 10993-16:1997

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 1174-3:1996

EN 1174-2:1996

Date Expired

(31.10.2006)

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

Date Expired

(31.7.2006)

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

—

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. |
| --- | --- |

—

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/

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(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) |
| --- | --- |

—

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) |
| --- | --- |

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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). |
| --- | --- |

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

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

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

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V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

Commission

| 9.11.2007 | EN | Official Journal of the European Union | C 267/31 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/31

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Notice of initiation of an anti-dumping proceeding concerning imports of certain iron or steel fasteners originating in the People's Republic of China

(2007/C 267/11)

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 (‘the basic Regulation’) (1), alleging that imports of certain fasteners of iron or steel, originating in the People's Republic of China (‘the country concerned’), are being dumped and are thereby causing material injury to the Community industry.

1.   Complaint

The complaint was lodged on 26 September 2007 by the European Industrial Fasteners Institute (EIFI) (‘the complainant’) on behalf of producers representing a major proportion, in this case more than 25 %, of the total Community production of certain fasteners of iron or steel.

2.   Product

The product allegedly being dumped is certain iron or steel fasteners, other than of stainless steel, i.e. wood screws (excluding coach screws), self-tapping screws, other screws and bolts with heads (whether or not with their nuts or washers, but excluding screws turned from bars, rods, profiles or wire, of solid section, of shank thickness not exceeding 6 mm and excluding screws and bolts for fixing railway track construction material) and washers, originating in the People's Republic of China (‘the product concerned’), normally declared within CN codes 7318 12 90, 7318 14 91, 7318 14 99, 7318 15 59, 7318 15 69, 7318 15 81, 7318 15 89, 7318 15 90, 7318 21 00 and 7318 22 00. These CN codes are only given for information.

3.   Allegation of dumping

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

On this basis, the dumping margin calculated is significant.

4.   Allegation of injury

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

5.   Procedure

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

5.1.   Procedure for the determination of dumping and injury

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

(a)   Sampling

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

(i)   Sampling for exporters/producers in the People's Republic of China

In order to enable the Commission to decide whether sampling is necessary and, if so, to select a sample, all exporters/producers, or representatives acting on their behalf, are hereby requested to make themselves known by contacting the Commission and providing the following information on their company or companies within the time limit set in point 6(b)(i) and in the format indicated in point 7:

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

—

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

| — | the turnover in local currency and the volume in tonnes of the product concerned manufactured by your company and sold for export to the Community during the period 1 October 2006-30 September 2007, |
| --- | --- |

—

the turnover in local currency and the volume in tonnes of the product concerned manufactured by your company and sold for export to the Community during the period 1 October 2006-30 September 2007,

| — | the turnover in local currency and the volume in tonnes of the product concerned manufactured by your company and sold on the domestic market during the period 1 October 2006-30 September 2007, |
| --- | --- |

—

the turnover in local currency and the volume in tonnes of the product concerned manufactured by your company and sold on the domestic market during the period 1 October 2006-30 September 2007,

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

—

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

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

—

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

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

—

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

By providing the above information, the company agrees to its possible inclusion in the sample. If the company is chosen to be part of the sample, this will imply replying to a questionnaire and accepting an on-the-spot investigation of its response. If the company indicates that it does not agree to its possible inclusion in the sample, it will be deemed to not have co-operated in the investigation. The consequences of non-cooperation are set out in point 8 below.

In order to obtain the information it deems necessary for the selection of the sample of exporters/producers, the Commission will, in addition, contact the authorities of the exporting country, and any known associations of exporters/producers.

(ii)   Sampling for importers

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

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

—

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

| — | the total turnover in euro of the company during the period 1 October 2006-30 September 2007, |
| --- | --- |

—

the total turnover in euro of the company during the period 1 October 2006-30 September 2007,

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

—

the total number of employees,

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

—

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

| — | the volume in tonnes and value in euro of imports into and resales made in the Community market during the period 1 October 2006-30 September 2007 of the imported product concerned originating in the People's Republic of China, |
| --- | --- |

—

the volume in tonnes and value in euro of imports into and resales made in the Community market during the period 1 October 2006-30 September 2007 of the imported product concerned originating in the People's Republic of China,

| — | the names and the precise activities of all related companies (3) involved in the production and/or selling of the product concerned, |
| --- | --- |

—

the names and the precise activities of all related companies (3) involved in the production and/or selling of the product concerned,

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

—

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

By providing the above information, the company agrees to its possible inclusion in the sample. If the company is chosen to be part of the sample, this will imply replying to a questionnaire and accepting an on-the-spot investigation of its response. If the company indicates that it does not agree to its possible inclusion or inclusion in the sample, it will be deemed to not have co-operated in the investigation. The consequences of non-cooperation are set out in point 8 below.

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

(iii)   Sampling for Community producers

In view of the large number of Community producers supporting the complaint, the Commission intends to investigate injury to the Community industry by applying sampling.

In order to enable the Commission to select a sample, all Community producers are hereby requested to provide the following information on their company or companies within the time limit set in point 6(b)(i):

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

—

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

| — | the total turnover in euro of the company during the period 1 October 2006-30 September 2007, |
| --- | --- |

—

the total turnover in euro of the company during the period 1 October 2006-30 September 2007,

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

—

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

| — | the value in euro of sales of the product concerned made in the Community market during the period 1 October 2006-30 September 2007, |
| --- | --- |

—

the value in euro of sales of the product concerned made in the Community market during the period 1 October 2006-30 September 2007,

| — | the volume in tonnes of sales of the product concerned made in the Community market during the period 1 October 2006-30 September 2007, |
| --- | --- |

—

the volume in tonnes of sales of the product concerned made in the Community market during the period 1 October 2006-30 September 2007,

| — | the volume in tones of the production of the product concerned during the period 1 October 2006-30 September 2007, |
| --- | --- |

—

the volume in tones of the production of the product concerned during the period 1 October 2006-30 September 2007,

| — | the names and the precise activities of all related companies (3) involved in the production and/or selling of the product concerned, |
| --- | --- |

—

the names and the precise activities of all related companies (3) involved in the production and/or selling of the product concerned,

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

—

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

By providing the above information, the company agrees to its possible inclusion in the sample. If the company is chosen to be part of the sample, this will imply replying to a questionnaire and accepting an on-the-spot investigation of its response. If the company indicates that it does not agree to its possible inclusion or inclusion in the sample, it will be deemed to not have co-operated in the investigation. The consequences of non-cooperation are set out in point 8 below.

(iv)   Final selection of the samples

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

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

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

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

(b)   Questionnaires

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

Exporters/producers in the People's Republic of China claiming an individual margin, with a view to the application of Articles 17(3) and 9(6) of the basic Regulation, must submit a completed questionnaire within the time limit set in point 6(a)(ii) of this notice. They therefore have to request a questionnaire within the time limit set in point 6(a)(i). However, such parties should be aware that if sampling is applied to exporters/producers, the Commission may nonetheless decide not to calculate an individual margin for them, if the number of exporters/producers is so large that individual examination would be unduly burdensome and would prevent the timely completion of the investigation.

(c)   Collection of information and holding of hearings

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

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(a)(iii).

(d)   Selection of the market economy country

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

(e)   Market economy treatment

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

5.2.   Procedure for assessment of Community interest

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

6.   Time limits

(a)   General time limits

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

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

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

All interested parties, if their representations are to be taken into account during the investigation, must make themselves known by contacting the Commission, present their views and submit questionnaire replies or any other information within 40 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. All exporters/producers concerned by this proceeding, who wish to apply for individual examination in accordance with Article 17(3) of the basic Regulation, must also submit a questionnaire reply within 40 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. Attention is drawn to the fact that the exercise of most procedural rights set out in the basic Regulation depends on the party's making itself known within the aforementioned period.

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

(iii)   Hearings

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

(b)   Specific time limit in respect of sampling

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

(i)

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

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

(ii)

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

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

(iii)

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

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

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

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

Duly substantiated claims for market economy treatment (as mentioned in point 5.1(e)) and/or for individual treatment pursuant to Article 9(5) of the basic Regulation, must reach the Commission within 15 days of the date of publication of this notice in the Official Journal of the European Union.

7.   Written submissions, questionnaire replies and correspondence

All submissions and requests made by interested parties must be made in writing (not in electronic format, unless otherwise specified and must indicate the name, address, e-mail address, telephone and fax 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’ (4) 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 |

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

Please note 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 (5).

11.   Hearing Officer

Please note that if you consider that you are encountering difficulties in the exercise of your rights of defence, you 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 your interests in this proceeding, in particular with regard to issues concerning access to the file, confidentiality, extension of time limits and the treatment of written and/or oral submission of views. For further information and contact details, see the Hearing Officer's web pages on the website of DG Trade (http://ec.europa.eu/trade).

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(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)  For guidance on the meaning of related companies, please refer to Article 143 of Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (OJ L 253, 11.10.1993, p. 1).

(3)  For guidance on the meaning of related companies, please refer to Article 143 of Regulation (EEC) No 2454/93.

(4)  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).

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

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PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 9.11.2007 | EN | Official Journal of the European Union | C 267/36 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/36

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

(Notice regarding an application for an exclusive licence to prospect for oil and gas, designated the ‘Nogent-sur-Seine Licence’)

(Text with EEA relevance)

(2007/C 267/12)

By application of 21 May 2007, Toreador Energy France S C S, a company with registered offices at 9, rue Scribe, F-75009 Paris, applied for an exclusive four-year licence, designated the ‘Nogent-sur-Seine Licence’, to prospect for liquid and gaseous hydrocarbons in an area of approximately 398 square kilometres covering part of the departments of Aube, Marne and Seine-et-Marne.

This request partially overlaps with the application dated 28 February 2007 submitted by Renouveau Energie Ressources, a company with registered offices at 16, rue de Vivienne, F-75002 Paris, for a licence, designated the ‘La Folie de Paris Licence’, to prospect for liquid and gaseous hydrocarbons in an area of approximately 962 square kilometres covering part of the departments of Seine-et-Marne, Marne and Aube.

This notice concerns only the area which is not the subject of the overlap. The perimeter of that area is made up of the meridian and parallel arcs successively joining the vertices defined below by their geographical coordinates, the original meridian being that of Paris.

| Vertices | Longitude | Latitude |
| --- | --- | --- |
| A | 1,10 °E | 53,90 °N |
| B | 1,30 °E | 53,90 °N |
| C | 1,30 °E | 53,80 °N |
| D | 1,10 °E | 53,80 °N |

Vertices

Longitude

Latitude

A

1,10 °E

53,90 °N

B

1,30 °E

53,90 °N

C

1,30 °E

53,80 °N

D

1,10 °E

53,80 °N

Submission of applications

The initial applicant and competing applicants must prove that they meet the requirements, as specified in Articles 4 and 5 of Decree No 2006-648 of 2 June 2006 concerning mining rights and underground storage rights (Journal officiel de la République française of 3 June 2006).

Interested companies may, within a period of ninety days of the publication of this notice, submit a competing application in accordance with the procedure summarised in the ‘Notice regarding the granting of mining rights for hydrocarbons in France’ published in
  Official Journal of the European Communities C 374 of 30 December 1994, p. 11, and established by Decree No 2006-648 concerning mining rights and underground storage rights (décret relatif aux titres miniers et aux titres de stockage souterrain). Competing applications must be sent to the Minister responsible for mines at the address below.

Criteria and deadline for awarding rights

The decisions on the initial application and competing applications will be based on the criteria governing the award of mining rights, as set out in Article 6 of the abovementioned Decree, and will be taken within two years of the date on which the French authorities received the La Folie de Paris Licence, i.e. by 2 March 2009 at the latest.

Conditions and requirements regarding performance of the activity and cessation thereof

Applicants are referred to Articles 79 and 79(1) of the Mining Code (code minier) and to Decree No 2006-649 of 2 June 2006 on mining and underground storage operations and the regulations governing mining and underground storage (décret relatif aux travaux miniers, aux travaux de stockage souterrain et à la police des mines et des stockages souterrains) (Journal officiel de la République française of 3 June 2006).

Further information can be obtained from the Ministry of Ecology and Sustainable Development: Ministère de l'écologie, du développement et de l'aménagement durables (direction générale de l'énergie et des matières premières, direction des ressources énergétiques et minérales, bureau de la législation minière), 61, boulevard Vincent Auriol, Télédoc 133, F-75703 Paris Cedex 13 (Telephone (33) 144 97 23 02 or (33) 153 94 14 72, fax (33) 144 97 05 70)).

The abovementioned laws and regulations can be consulted at:

http://www.legifrance.gouv.fr

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

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| 9.11.2007 | EN | Official Journal of the European Union | C 267/38 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/38

---

Prior notification of a concentration

(Case COMP/M.4803 — RBS/Sempra)

Candidate case for simplified procedure

(Text with EEA relevance)

(2007/C 267/13)

| 1. | On 5 November 2007, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Royal Bank of Scotland Group Plc (‘RBS’, UK) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of parts of the Sempra Energy Group (‘Sempra Companies’, USA), by way of creating a partnership RBS Sempra Commodities LLP (‘Partnership’, UK). |
| --- | --- |

1.

On 5 November 2007, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Royal Bank of Scotland Group Plc (‘RBS’, UK) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of parts of the Sempra Energy Group (‘Sempra Companies’, USA), by way of creating a partnership RBS Sempra Commodities LLP (‘Partnership’, UK).

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






  — | for RBS: provider of banking services and integrated financial solutions, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for RBS: provider of banking services and integrated financial solutions,

| — | for Sempra Companies: principally physical commodities trading and associated activities, worldwide. |
| --- | --- |

—

for Sempra Companies: principally physical commodities trading and associated activities, worldwide.

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

3.

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

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4803 — RBS/Sempra, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4803 — RBS/Sempra, 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.

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| 9.11.2007 | EN | Official Journal of the European Union | C 267/39 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/39

---

Prior notification of a concentration

(Case COMP/M.4513 — Arjowiggins/M-real Zanders Reflex)

(Text with EEA relevance)

(2007/C 267/14)

| 1. | On 31 October 2007, 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 Arjowiggins SAS (‘Arjowiggins’, France), controlled by Sequana Capital (formerly known as Worms & Cie) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of M-real Zanders Reflex mill situated in Düren, Germany (‘Reflex’), part of M-real Corporation (‘M-real Group’, Finland), by way of purchase of assets. |
| --- | --- |

1.

On 31 October 2007, 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 Arjowiggins SAS (‘Arjowiggins’, France), controlled by Sequana Capital (formerly known as Worms & Cie) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of M-real Zanders Reflex mill situated in Düren, Germany (‘Reflex’), part of M-real Corporation (‘M-real Group’, Finland), by way of purchase of assets.

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






  — | for Arjowiggins: production and distribution of specialty paper such as graphic paper and carbonless copy paper, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Arjowiggins: production and distribution of specialty paper such as graphic paper and carbonless copy paper,

| — | for Reflex: production and distribution of carbonless paper and other specialty paper. |
| --- | --- |

—

for Reflex: production and distribution of carbonless paper and other specialty paper.

| 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. |
| --- | --- |

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.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4513 — Arjowiggins/M-real Zanders Reflex, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4513 — Arjowiggins/M-real Zanders Reflex, 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.

---

OTHER ACTS

Commission

| 9.11.2007 | EN | Official Journal of the European Union | C 267/40 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/40

---

Publication of an application pursuant to Article 8(2) of Council Regulation (EC) No 509/2006 on agricultural products and foodstuffs as traditional specialities guaranteed

(2007/C 267/15)

This publication confers the right to object to the application pursuant to Article 9 of Council Regulation (EC) No 509/2006 (1). Statements of objection must reach the Commission within six months from the date of this publication.

APPLICATION FOR REGISTRATION OF A TSG

COUNCIL REGULATION (EC) No 509/2006

‘PÓŁTORAK’

EC No PL/TSG/007/0034/06.09.2005

1.   Name and address of the applicant group

| Name: | Krajowa Rada Winiarstwa i Miodosytnictwa przy Stowarzyszeniu Naukowo — Technicznym Inżynierów i Techników Przemysłu Spożywczego |
| --- | --- |
| Address: | ul. Czackiego 3/6 |
| PL-00-043 Warszawa |

Name:

Krajowa Rada Winiarstwa i Miodosytnictwa przy Stowarzyszeniu Naukowo — Technicznym Inżynierów i Techników Przemysłu Spożywczego

Address:

ul. Czackiego 3/6

PL-00-043 Warszawa

Tel.

(48-22) 828 27 21

E-mail:

krwim@sitspoz.pl

2.   Member State or Third Country

Poland

3.   Product Specification

3.1.   Name to be registered

‘Półtorak’

When the product is placed on the market, the label may contain the following information: ‘miód pitny wytworzony zgodnie ze staropolską tradycją’ (mead produced in accordance with an old Polish tradition). This information should be translated into other official languages.

3.2.   Whether the name

| | is specific in itself |
| --- | --- |
| | expresses the specific character of the agricultural product or foodstuff |

Image

is specific in itself

Image

expresses the specific character of the agricultural product or foodstuff

The name ‘półtorak’ derives from the numeral ‘1,5’ (PL: ‘półtora’) and relates directly to the historically established composition and method of production of ‘półtorak’ — the proportions of honey and water in the mead wort being one part honey to 0,5 part water. The name therefore expresses the specific character of the product. Since the term ‘półtorak’ is a word that is used solely to denote a specific type of mead, the name should also be considered to be specific in itself.

3.3.   Whether reservation of the name is sought under Article 13(2) of Regulation (EC) No 509/2006

| | Registration with reservation of the name |
| --- | --- |
| | Registration without reservation of the name |

Image

Registration with reservation of the name

Image

Registration without reservation of the name

3.4.   Type of product

Class 1.8 — Other products of Annex I

3.5.   Description of the agricultural product or foodstuff to which the name under point 3.1 applies

‘Półtorak’ is a mead, a clear beverage fermented from mead wort, distinguished by its characteristic honey aroma and the taste of the raw material used.

The flavour of ‘półtorak’ may be enriched by the taste of spices that are used. The colour of ‘półtorak’ ranges from golden to dark amber and depends on the type of honey used for production.

The physico-chemical indicators typical for ‘półtorak’ mead are:

| — | alcohol content: 15-18 % vol., |
| --- | --- |

—

alcohol content: 15-18 % vol.,

| — | reducing sugars after inversion: more than 300 g/l, |
| --- | --- |

—

reducing sugars after inversion: more than 300 g/l,

| — | total acidity expressed as malic acid: 3,5-8 g/l, |
| --- | --- |

—

total acidity expressed as malic acid: 3,5-8 g/l,

| — | volatile acidity expressed as acetic acid: max. 1,4 g/l, |
| --- | --- |

—

volatile acidity expressed as acetic acid: max. 1,4 g/l,

| — | total sugar (g) plus actual alcohol content (% vol.) multiplied by 18: min. 600 g, |
| --- | --- |

—

total sugar (g) plus actual alcohol content (% vol.) multiplied by 18: min. 600 g,

| — | non-sugar extract: not less than:






  — | 30 g/l, |
| --- | --- | --- |

—

non-sugar extract: not less than:

—

30 g/l,

| — | 35 g/l in the case of fruit mead (melomel), |
| --- | --- |

—

35 g/l in the case of fruit mead (melomel),

| — | ash: min. 1,3 g/l — in the case of fruit mead. |
| --- | --- |

—

ash: min. 1,3 g/l — in the case of fruit mead.

The use of preservatives, stabilisers and artificial colourings and flavourings is prohibited in the production of ‘półtorak’.

3.6.   Description of the production method of the agricultural product or foodstuff to which the name under point 3.1 applies

Raw materials

| — | Natural honey with the following parameters:






  — | water content: max. 20 % (m/m), |
| --- | --- | --- |

—

Natural honey with the following parameters:

—

water content: max. 20 % (m/m),

| — | reducing sugar content: min. 70 % (m/m), |
| --- | --- |

—

reducing sugar content: min. 70 % (m/m),

| — | combined sucrose and melezitose content: max. 5 % (m/m), |
| --- | --- |

—

combined sucrose and melezitose content: max. 5 % (m/m),

| — | total acidity — 1 mol/l NaOH solution per 100 g of honey: within the range 1-5 ml, |
| --- | --- |

—

total acidity — 1 mol/l NaOH solution per 100 g of honey: within the range 1-5 ml,

| — | 5-hydroxy-methyl-furfurol (HMF) content: max. 4,0 mg per 100 g honey. |
| --- | --- |

—

5-hydroxy-methyl-furfurol (HMF) content: max. 4,0 mg per 100 g honey.

| — | High-attenuation mead yeast — suitable for attenuation of high extracts in pitched wort. |
| --- | --- |

—

High-attenuation mead yeast — suitable for attenuation of high extracts in pitched wort.

| — | Herbs and spices: cloves, cinnamon, nutmeg or ginger. |
| --- | --- |

—

Herbs and spices: cloves, cinnamon, nutmeg or ginger.

| — | Natural fruit juices or fresh fruit. |
| --- | --- |

—

Natural fruit juices or fresh fruit.

| — | Ethyl alcohol of agricultural origin (possibly). |
| --- | --- |

—

Ethyl alcohol of agricultural origin (possibly).

Production method

Stage 1

Brewing (boiling) of the mead wort at a temperature of 95-105 °C. The required proportions of honey and water for ‘półtorak’ are one part honey to 0,5 part water (or water mixed with fruit juice) in the finished product. As the sugar concentration is too high for the yeast to work in the fermentation process, a wort with the following proportions is prepared: one part honey to two parts water, to which herbs or spices may be added. In the case of fruit meads, at least 30 % of the water is replaced with fruit juice. In order to maintain the appropriate proportions of honey and water that are characteristic of ‘półtorak’, the rest of the honey is added in the final stage of fermentation or during ageing.

Strict adherence to the proportions of water and honey and obtaining the required extract in a wort kettle fitted with a steam jacket. This method of brewing prevents caramelisation of the sugars.

Stage 2

Cooling of the wort to 20-22 °C, the optimum temperature for yeast to propagate. The wort must be cooled on the day of production, and the cooling time depends on the efficiency of the cooler. Cooling guarantees the microbiological safety of the wort.

Stage 3

Pitching, addition of a yeast solution to the wort in a fermentation tank.

Stage 4

| A. | Violent fermentation: 6-10 days. Keeping the temperature at a maximum level of 28 °C ensures that the fermentation process runs properly. |
| --- | --- |

A.

Violent fermentation: 6-10 days. Keeping the temperature at a maximum level of 28 °C ensures that the fermentation process runs properly.

| B. | Still fermentation: 3-6 weeks. The still fermentation period ensures that the proper physico-chemical parameters are attained. |
| --- | --- |

B.

Still fermentation: 3-6 weeks. The still fermentation period ensures that the proper physico-chemical parameters are attained.

At this stage it is possible to add the remaining quantity of honey to achieve the required proportion in ‘półtorak’.

Stage 5

Racking of the attenuated pitched wort.

After obtaining an alcohol content of at least 12 % vol., racking prior to ageing should be carried out. This guarantees that the mead has the appropriate physico-chemical and organoleptic properties. Leaving the pitched wort on the lees beyond the still fermentation period adversely affects the organoleptic properties, owing to yeast autolysis.

Stage 6

Ageing (maturing) and siphoning (decanting) — this is repeated as necessary to prevent unwanted processes from taking place in the lees (yeast autolysis). During ageing it is possible to carry out operations such as pasteurisation and filtration. At this stage it is possible to add the remaining quantity of honey to achieve the required proportion in ‘półtorak’, if this has not been done in the final phase of fermentation. This stage is essential for ensuring that the product has the right organoleptic properties.

The minimum ageing time for ‘półtorak’ is three years.

Stage 7

Flavour-adjustment (composition) — this stage concerns the preparation of a final product having the organoleptic and physico-chemical properties appropriate to ‘półtorak’, as specified in point 3.5 — Description of the agricultural product or foodstuff. In order to ensure that the required parameters are attained, it is possible to correct the organoleptic and physico-chemical properties by:

| — | adding honey to sweeten the mead, |
| --- | --- |

—

adding honey to sweeten the mead,

| — | adding herbs and spices, |
| --- | --- |

—

adding herbs and spices,

| — | adding ethyl alcohol of agricultural origin. |
| --- | --- |

—

adding ethyl alcohol of agricultural origin.

The aim of this stage is to obtain a product with the characteristic ‘półtorak’ bouquet.

Stage 8

Pouring into unit containers at a temperature of 18-25 °C. It is recommended that ‘półtorak’ be presented in traditional packaging, such as: carboys, ceramic containers or oak barrels.

3.7.   Specific character of the agricultural product or foodstuff

The specific character of ‘półtorak’ results from:

| — | the preparation of the wort (composition and proportion of raw materials), |
| --- | --- |

—

the preparation of the wort (composition and proportion of raw materials),

| — | ageing and maturing, |
| --- | --- |

—

ageing and maturing,

| — | its physico-chemical and organoleptic properties. |
| --- | --- |

—

its physico-chemical and organoleptic properties.

Preparation of the wort (composition)

The specific character of ‘półtorak’ results in particular from the use of, and strict adherence to, the established proportions of honey and water — one part honey to 0,5 parts water — in the mead wort. This proportion is the determining factor in all further stages in the production of ‘półtorak’ that impart its unique properties.

Ageing and maturing

According to the traditional old Polish recipe, the character of the product depends on its being aged and matured for a specified period of time. In the case of ‘półtorak’ this period is at least three years.

Physico-chemical and organoleptic properties

Observance of all the stages of production included in the specification ensures that a product of unique taste and aroma is obtained. The unique taste and odour of ‘półtorak’ is the result of appropriate sugar and alcohol content:

| — | reducing sugars after inversion: > 300 g/l, |
| --- | --- |

—

reducing sugars after inversion: > 300 g/l,

| — | total sugar (g) plus actual alcohol content (% vol.) multiplied by 18: min. 600 g, |
| --- | --- |

—

total sugar (g) plus actual alcohol content (% vol.) multiplied by 18: min. 600 g,

| — | alcohol: 15-18 % vol. |
| --- | --- |

—

alcohol: 15-18 % vol.

Owing to strictly defined proportions of the ingredients used in its production, ‘półtorak’ possesses a typically viscous and runny consistency which distinguishes it from other types of mead.

3.8.   Traditional character of the agricultural product or foodstuff

Traditional production method

Mead production in Poland is a tradition which dates back over a thousand years and is characterised by great diversity. The development and improvement of the production method over the centuries has given rise to many types of mead. The history of mead production dates back to the beginnings of Poland's statehood In 966 the Spanish diplomat, merchant and traveller, Ibrahim ibn Yaqub, wrote: ‘Besides food, meat and land for ploughing, the country of Mieszko I abounds in mead, which is what the Slavic wines and intoxicating drinks are called’ (Mieszko I was the first historic king of Poland). The Chronicles of Gallus Anonymus, who recorded Polish history at the turn of the 11th and 12th centuries, also contain numerous references to the production of mead.

The Polish national epic poem ‘Pan Tadeusz’ by Adam Mickiewicz, which tells the story of the nobility between 1811 and 1812, contains a good deal of information on the production, consumption and different types of mead. Mentions of mead can also be found in the poems of Tomasz Zan (1796-1855) and in Henryk Sienkiewicz's trilogy describing events in Poland in the 17th century (‘Ogniem i mieczem’, published in 1884; ‘Potop’, published in 1886 and ‘Pan Wołodyjowski’, published in 1887 and 1888).

Source materials describing Polish culinary traditions of the 17th and 18th centuries contain not only general references to mead, but also references to different types of mead. Depending on the production method, they were called ‘półtorak’, ‘dwójniak’, ‘trójniak’ and ‘czwórniak’. Each of these names relates to a different type of mead, produced on the basis of different proportions of honey and water or juice, and different ageing times. The ‘półtorak’ production technique has been used, with minor modifications, for centuries.

Traditional composition

The traditional division of mead into ‘półtorak’, ‘dwójniak’, ‘trójniak’ and ‘czwórniak’ has existed in Poland for centuries and still exists in consumers' consciousness to this day. After the Second World War attempts were made to regulate the traditional division of mead into four categories. This division was finally enshrined in Polish law in 1948 by means of the Act on the production of wines, wine musts, meads and trade in such products (Journal of Laws of the Republic of Poland of 18 November 1948). This Act contains rules on the production of meads, specifying the proportions of honey and water and the technological requirements. The proportions of water and honey for ‘półtorak’ are given as follows: ‘Only mead produced from one part natural honey and a half part water may be called “półtorak”’.

3.9.   Minimum requirements and procedures to check the specific character

Mandatory checking encompasses

| — | adherence to the established proportions of ingredients in the mead wort, |
| --- | --- |

—

adherence to the established proportions of ingredients in the mead wort,

| — | adherence to the length of the ageing time, |
| --- | --- |

—

adherence to the length of the ageing time,

| — | organoleptic properties of the finished product (taste, odour, colour, clarity), |
| --- | --- |

—

organoleptic properties of the finished product (taste, odour, colour, clarity),

| — | physico-chemical indicators of the finished product: alcohol content, total sugar, reducing sugar after inversion, total acidity, volatile acidity, non-sugar extract, and ash in the case of fruit meads — the values should correspond to the values specified at point 3.5 of the specification. |
| --- | --- |

—

physico-chemical indicators of the finished product: alcohol content, total sugar, reducing sugar after inversion, total acidity, volatile acidity, non-sugar extract, and ash in the case of fruit meads — the values should correspond to the values specified at point 3.5 of the specification.

Mandatory checks are carried out at least once a year.

It is recommended that checks also be carried out during the production stages listed below. Checks at the production stages listed below are not mandatory, but are advisable, because they help eliminate possible errors occurring at different stages of production:

Stage 4

During the fermentation process, regular laboratory tests should be carried out on organoleptic properties (taste and odour) and physico-chemical parameters such as alcohol content and content of sugars that are subject to change during the alcoholic fermentation process.

Stage 6

During ageing, regular checks should be carried out on the basic organoleptic properties of the product and physico-chemical indicators such as alcohol content, total sugar, total acidity and volatile acidity.

Stage 8

Before bottling, checks are carried out on the various physico-chemical and organoleptic parameters specified at 3.5 — Description of the agricultural product or foodstuff.

4.   Authorities or bodies verifying compliance with the product specification

4.1.   Name and address

| Name: | Główny Inspektorat Jakości Handlowej Artykułów Rolno — Spożywczych |
| --- | --- |
| Address: | ul. Wspólna 30, PL-00-930 Warszawa |
| Tel. | (48-22) 623 29 00 |
| Fax | (48-22) 623 29 98 |
| E-mail: | — |

Name:

Główny Inspektorat Jakości Handlowej Artykułów Rolno — Spożywczych

Address:

ul. Wspólna 30, PL-00-930 Warszawa

Tel.

(48-22) 623 29 00

Fax

(48-22) 623 29 98

E-mail:

—

| | Public |
| --- | --- |

Image

Public

| | Private |
| --- | --- |

Image

Private

4.2.   Specific tasks of the authority or body

The inspection authority above is responsible for the verification of the entirety of the specification.

---

(1)  OJ L 93, 31.3.2006, p. 1.

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| 9.11.2007 | EN | Official Journal of the European Union | C 267/46 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/46

---

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

(2007/C 267/16)

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006 (1). Statements of objection must reach the Commission within six months from the date of this publication.

SUMMARY

COUNCIL REGULATION (EC) No 510/2006

‘AGNEAU DE LOZERE’

EC No: FR/PGI/005/0501/06.10.2005

PDO ( ) PGI ( X )

This summary sets out the main elements of the product specification for information purposes.

1.   Responsible department in the Member State:

| Name: | Institut National des Appellations d'Origine (I.N.A.O.) |
| --- | --- |
| Address: | 51, rue d'Anjou |
| F-75008 Paris |

Name:

Institut National des Appellations d'Origine (I.N.A.O.)

Address:

51, rue d'Anjou

F-75008 Paris

Tel.

(33) 153 89 80 00

Fax

(33) 142 25 57 97

E-mail:

info@inao.gouv.fr

2.   Group:

| Name: | Association Viande d'Agneau de Lozère (A.V.A.L.) |
| --- | --- |
| Address: | c/o Cobevial |
| Avenue Pierre Sémard |
| F-48100 Marvejols |

Name:

Association Viande d'Agneau de Lozère (A.V.A.L.)

Address:

c/o Cobevial

Avenue Pierre Sémard

F-48100 Marvejols

Tel.

(33) 466 32 43 08

Fax

(33) 466 32 04 02

E-mail:

cobevial-48@wanadoo.fr

Composition:

Producers/processors ( X ) Other ( X )

3.   Type of product:

Class 1.1: Fresh meat (and offal)

4.   Specification:

(Summary of requirements under Article 4(2) of Regulation (EC) No 510/2006)

4.1   Name: ‘Agneau de Lozère’

4.2   Description: The characteristics of the product concerned by the PGI are as follows:

Breed: male and female Blanche du Massif Central breeding stock.

Type of animal: The lambs (male and female) are young and light, just on the threshold between suckling and grass-fed lamb. They are not separated from their mothers before being taken from the holding but suckle until natural weaning, and are never fed formula milk.

Rearing method: the rearing method is economical, based on the optimum use of grazing resources in the PGI area. The aim is to put the herd out to pasture as much as possible. Systematic use of areas of pasture on the holdings is a measure of the special character of the product. This distinguishes it from lambs raised in more intensive areas. As the mothers feed on land with varied vegetation and few inputs, their milk impacts on the lambs.

The lambs are slaughtered at not more than 130 days of age.

Carcase characteristics:

lamb carcase weight of between 7 and 19 kg,

conformation: U, R, O in the EUROP grading scale,

fat cover: classes 2 and 3 in the EUROP grading scale,

colour: pinky white,

fat quality: firm, malleable white fat.

The sheepmeat is sold fresh:

as whole and half-carcases,

in small wholesale cuts,

in ready-to-cut portions (Prêt A Découper, PAD),

in consumer sales units (Unité de Vente Consommateur, UVC).

4.3   Geographical area: The lambs are born, raised and slaughtered in the PGI area.

The ‘Agneau de Lozère’ PGI area is defined by the following criteria:

Presence of Blanche du Massif Central (BMC) ewes.

| — | Criterion used: presence of BMC: over 500 BMC ewes present in each canton. |
| --- | --- |

—

Criterion used: presence of BMC: over 500 BMC ewes present in each canton.

Rising altitude, on a South-East/North-West axis.

| — | Criterion used: cantons situated above 800 metres or at an altitude varying between 600 and 800 metres. |
| --- | --- |

—

Criterion used: cantons situated above 800 metres or at an altitude varying between 600 and 800 metres.

Pastureland with poor productive capacity rising on a North-West/South-East axis.

| — | Criterion used: more than 20 % unproductive permanent grassland (Surface Toujours en Herbe, STH). |
| --- | --- |

—

Criterion used: more than 20 % unproductive permanent grassland (Surface Toujours en Herbe, STH).

No volcanic subsoils, as these lead to more intensive production of animals and per hectare.

The geographical area consists of 259 municipalities in 4 departments.

—   Département de la Lozère (48): the whole Department (185 municipalities).

—   Département du Cantal (15): 33 municipalities: Alleuze, Anglards-de-Saint-Flour, Anterrieux, Celoux, Chaliers, Chaudes-Aigues, Chazelles, Clavieres, Coren, Deux-Verges, Espinasse, Faverolles, Fridefont, Jabrun, Lieutades, Lorcieres, Loubaresse, Maurines, Mentieres, Montchamp, Rageade, Ruynes-en-Margeride, Saint-Georges, Saint-Just, Saint-Marc, Saint-Martial, Saint-Remy-de-Chaudes-Aig, Saint-Urcize, Soulages, Tiviers, Trinitat, Vabres, Vedrines-Saint-Loup.

—   Département de l'Ardèche (07): 11 municipalities: Borne, Cellier-du-Luc, Laval-d'Aurelle, Laveyrune, Lesperon, Malarce-sur-la-Thines, Montselgues, Saint-Alban-en-Montagne, Saint-Etienne-de-Lugdares, Saint-Laurent-les-Bains, Sainte-Marguerite-Lafiger.

—   Département de la Haute Loire (43): 30 municipalities: Alleyras, Ally, Arlet, Auvers, Besseyre-Saint-Mary, Chanaleilles, Charraix, Hastel, Chazelles, Croisances, Cronce, Cubelles, Desges, Esplantas, Ferrussac, Grezes, Langeac, Monistrol-d'Allier, Pebrac, Pinols, Prades, Saint-Austremoine, Saint-Christophe-d'Allier, Saint-Prejet-d'Allier, Saint-Venerand, Saugues, Tailhac, Thoras, Vazeilles-près-Saugues, Venteuges.

4.4   Proof of origin: Traceability is guaranteed from birth until the meat is sold to consumers. Sheepfarmers are required to keep herd registers up-to-date and to identify their animals in line with the rules.

Animals which are excluded from the PGI procedure are marked with a red cross on their back.

Animals which are eligible for the PGI procedure are given a special eartag referring to the PGI.

Traceability of live animals is ensured through the animal's working number.

Traceability of carcases is ensured by the slaughterhouse number (in connection with the working number), and traceability of the cuts of meat by the batch number.

4.5   Method of production: Holdings must be authorised before they can produce Agneau de Lozère.

The lambs are born of ewes of the Blanche du Massif Central breed and rams of the same breed. The current aims of selection are to improve the qualities of the mother ewes, milk value (which impacts on fat quality and colour), prolificacy, growth and, above all, carcase quality (conformation and amount of fat).

The intensity is below 1,4 livestock units per hectare, or fewer than 10 ewes per hectare used (grassland, range: heath, undergrowth, summer mountain pasture).

Buildings must offer an internal area of around 1,5 m2 per ewe fed, if equipped with traditional troughs or with transverse feeding racks perpendicular to a central corridor. In buildings equipped with feeding racks the area required is just 1,3 m2 per ewe.

Feeding of mothers

In quantitative terms, the development of grazing resources is restricted by climate constraints (cold temperatures in winter, drought in summer, etc.) which reduce supply and the period of use. Thus, depending on the different times of year and on the physiological needs of the animals, farmers make use predominantly of grassland or of range. However, optimum use of grassland and range depends closely on the combined use of both, supplemented with other feed resources produced from range, grassland, fodder crops or dry fodder.

Farmers undertake to strive for self-sufficiency in fodder supply (harvested grass, grazed grass). 100 % of fodder consumed will therefore be harvested in the PGI area, apart from the dried alfalfa required as a source of protein. The fodder may be produced or purchased in the PGI area. However, the dried alfalfa purchased may not exceed 10 % of fodder consumed.

Feeding of lambs

During the first stage of their lives the lambs are fed exclusively from their mother's milk: they suckle until they are naturally weaned. There is contact between ewes and lambs at least twice a day for suckling to promote lactation for as long as possible. Lambs are not separated from their mothers until they are removed for slaughter.

At the end of the rearing period, on top of their mother's milk lambs may be given a feed supplement comprising at least 50 % cereals and cereal by-products. This feed supplement may make up no more than 31 % of the total ration and does not necessarily have to come from the PGI area.

Slaughter and cutting

The lambs are slaughtered in the PGI area. Cutting may be carried out outside the PGI area. The meat may be packaged under film, vacuum-packed or packaged under a modified atmosphere.

4.6   Link: BMC is a hardy breed which has been developed into a pure breed:

Historically, the Blanche du Massif Central (BMC) breed is considered to be one branch of a vast population of sheep termed ‘Caussenards’ which for more than 2 000 years inhabited the Causses, the dry regions with poor, stony soil bordering the Massif Central from the South to the South-West.

In recent decades the term ‘Blanc de Lozère’ appeared, marking a change in the population located in Margeride as breeders sought to obtain fuller and fatter animals from the best herds.

As the geographical area covered by the breed spread well beyond the boundaries of the area in which it originated, it finally took the less restrictive name ‘Blanche du Massif Central’ (BMC).

BMC advantages in terms of this rearing method: specific characteristics of this breed which make it particularly well-adapted to the territory:

The BMC breed has adapted particularly well to the different, sometimes difficult, almost entirely open-air herd management situations in dry, arid regions, and more continental mountain conditions. This quality gives farmers sheep which can tolerate the worst weather conditions on plateaux with no shelter, make do with whatever they find to eat and even walk long distances to find better grazing.

In Lozère, the continuing predominance of BMC over other sheep breeds in meat production is mainly down to its hardiness. The quality of this meat is determined by the PGI territory as it results from the specific nature of the diet of the mother ewes and lambs from this region.

By enduring with its special characteristics, the BMC breed today represents the key link to the area.

The importance of grazing in the rearing method

The rearing method (grazing) on which the production of the lambs covered by the PGI application rests is an economical system based on the optimum use of local resources: grazed grass, harvested grass and auto-consumed cereals.

Grazing therefore encompasses specific environments which, unlike areas such as grassland, lend themselves to traditional mechanised practices very little if at all, at least in an economically acceptable way. Grazing areas can be used rarely or not at all by other species such as cattle.

Hence the special character of ‘Agneau de Lozère’ rests on the combination of a high-quality product along with the purity of the breed and diversity of its feed, and an environmental consideration related to farming practices which make the best use of the natural environment and ancestral traditions.

A well-known meat

Despite the hardiness of the BMC breed, its meat is recognised as the best of the French hardy breeds. Sheepfarmers therefore manage the breed without cross-breeding.

‘Agneau de Lozère’ meat today has a very good reputation, as demonstrated by various press articles (general and specialist press) and testimonies from leading chefs (David Van Laer, Philippe Groult). World-famous local restaurateurs say that ‘Agneau de Lozère’ flesh is silky, its texture fine and firm and that the meat is ‘perfumed with the scent of grass’.

4.7   Inspection body:

| Name: | Qualisud, Organisme certificateur agréé EN 45011 |
| --- | --- |
| Address: | 2, rue des Remparts |
| F-40000 Mont-de-Marsan |

Name:

Qualisud, Organisme certificateur agréé EN 45011

Address:

2, rue des Remparts

F-40000 Mont-de-Marsan

Tel.

(33) 558 06 15 21

Fax

(33) 558 75 13 36

E-mail:

qualisud@wanadoo.fr

4.8   Labelling: Name of product: ‘Agneau de Lozère’.

The PGI logo or the words Indication Géographique Protégée (protected geographical indication) will be used on the labelling.

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(1)  OJ L 93, 31.3.2006, p. 12.

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| 9.11.2007 | EN | Official Journal of the European Union | C 267/50 |
| --- | --- | --- | --- |

9.11.2007

EN

Official Journal of the European Union

C 267/50

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Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

(2007/C 267/17)

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006 (1). Statements of objection must reach the Commission within six months from the date of this publication.

SUMMARY

COUNCIL REGULATION (EC) No 510/2006

‘MAZAPÁN DE TOLEDO’

EC No: ES/PGI/005/0291/14.05.2003

PDO ( ) PGI ( X )

This summary sets out the main elements of the product specification for information purposes.

1.   Responsible department in the Member State:

| Name: | Subdirección General de Calidad Agroalimentaria y Agricultura Ecológica. Dirección General de Industria Agroalimentaria y Alimentación. Subsecretaría de Agricultura, Pesca y Alimentación del Ministerio de Agricultura, Pesca y Alimentación |
| --- | --- |
| Address: | Paseo de la Infanta Isabel, no 1 |
| E-28071 Madrid |

Name:

Subdirección General de Calidad Agroalimentaria y Agricultura Ecológica. Dirección General de Industria Agroalimentaria y Alimentación. Subsecretaría de Agricultura, Pesca y Alimentación del Ministerio de Agricultura, Pesca y Alimentación

Address:

Paseo de la Infanta Isabel, no 1

E-28071 Madrid

Telephone

(34) 913 47 53 94

Fax

(34) 913 47 54 10

E-mail:

sgcaproagro@mapya.es

2.   Group:

| Name: | Consejo Regulador de la Indicación Geográfica Protegida Mazapán de Toledo |
| --- | --- |
| Address: | Paseo de Recaredo, no 1 |
| E-45002 Toledo |

Name:

Consejo Regulador de la Indicación Geográfica Protegida Mazapán de Toledo

Address:

Paseo de Recaredo, no 1

E-45002 Toledo

Telephone

(34) 925 22 87 10

Fax

(34) 925 21 18 12

E-mail:

—

Composition:

Producers/processors ( X ) Other ( )

3.   Type of product:

Class 2.4: Bread, pastry, cakes, confectionery, biscuits and other baker's wares

4.   Specification:

(Summary of requirements under Article 4(2) of Regulation (EC) No 510/2006)

4.1.   Name: ‘Mazapán de Toledo’

4.2.   Description: The name ‘mazapán de Toledo’ is given to the fine-grained solid paste produced by mixing together or kneading peeled, ground raw almonds and sugar or sugars.

Almonds are the main ingredient of ‘mazapán de Toledo’ and must constitute most of the paste, or at least be present in a 1:1 ratio (i.e. represent 50 % of the total weight). The almonds used to make ‘mazapán de Toledo’ are peeled sweet varieties with a minimum fat content of 50 %. It therefore follows that ‘mazapán de Toledo’ must have a minimum fat content of 26 % (corresponding to the minimum percentage of almonds required and their minimum fat content).

The organoleptic characteristics are assessed using the procedure for tasting ‘mazapán de Toledo’. This is based on two main categories:

olfactory-gustatory sensation: the assessment involves the senses of smell and taste, and represents 66,5 % of the total score,

texture: other oral sensations account for up to 33,5 % of the remaining score.

Products marketed with the PGI ‘mazapán de Toledo’ must obtain a minimum score of 48 points; none of the parameters for either tasting category may be marked as ‘substandard’ or ‘unacceptable’.

4.3.   Geographical area: The province of Toledo.

4.4.   Proof of origin: The most likely origin of the term ‘marzipan’ is the Arabic spoken in al-Andalus during the medieval period when races and cultures coexisted in central and southern Spain.

Following Arab rule, marzipan continued to be made in the city of Toledo, both in convents and other establishments. From that time on, marzipan has continuously been made by small-scale local and provincial producers using their vast know-how and experience.

To provide consumers with a guarantee of the authenticity of ‘mazapán de Toledo’, products bearing the protected geographical indication must be made by producers who are located in the province of Toledo and are subject to inspection by the product certification body forming part of the inspection body.

4.5.   Method of production:

| — | Raw almonds are peeled, moistened with one or more types of sugar and mixed together. |
| --- | --- |

—

Raw almonds are peeled, moistened with one or more types of sugar and mixed together.

| — | The almonds used to make ‘mazapán de Toledo’ are sweet peeled varieties with a minimum fat content of 50 %. The sugars used may be beet or cane sugar, honey, glucose, sucrose or other natural sugars. |
| --- | --- |

—

The almonds used to make ‘mazapán de Toledo’ are sweet peeled varieties with a minimum fat content of 50 %. The sugars used may be beet or cane sugar, honey, glucose, sucrose or other natural sugars.

| — | The mix is ground, kneaded and packaged. |
| --- | --- |

—

The mix is ground, kneaded and packaged.

4.6.   Link: Although sugar was not widely available in Europe until the 16th century, when large quantities were imported from America, there is no doubt that it was much used in al-Andalus and Sicily, from where it was imported into Castile, Catalonia, Portugal and mainland Italy. Sugar rivalled, or even replaced, honey in the preparation of a wide variety of delicious desserts and drinks.

Sugar was blended with dried fruit, especially almonds, to create pastries which are typically eastern and still exist in a wide variety of forms. They include Toledo marzipan, nougat (turrones), almond pastries, almond and pine nut pastries (empiñonadas) and sugar-coated almonds, as well as countless traditional sweets whose recipes are sometimes closely guarded. However, their names reveal that they are Arabic in origin, as is the case with Cuenca's alajú or Andalusia's alfajor (from the Arabic alhashu meaning ‘filled’).

Toledo turned confectionery into a fine art, imbued with numerous subtle variations, blends and happy discoveries. It drew on the Arab and Hebrew legacy, the fine work of nuns in enclosed convents and the painstaking labour of its confectioners. Toledo confectionery — without doubt its main distinguishing culinary feature — enjoyed huge prestige and renown. From his retreat in Yuste, Charles V, and later his son Philip II, would order for their table marzipan and other sweetmeats made in the imperial city. Toledo confectionery from that period is widely acknowledged to have been the best in Europe because of its variety, originality and refinement. The list of recipes is endless.

The first known recipe for ‘marzipan’ is in the Libro de guisados, manjares y potajes (Book of Stews, Delicacies and Soups) by the chef Ruperto de Nola, which was first published in Spanish in Toledo in 1525 to coincide with a visit by the Emperor Charles V.

King Philip III, by proclamation of 1615, approved the Decree establishing the Guild of Toledo Confectioners, section 10 of which refers to the making of marzipan as follows: ‘All marzipan must be made from syrup of almonds from Valencia and white sugar, and in no other way. Anyone failing to do so shall be fined one thousand maravedis in each case’.

There is also an extensive body of historical, literary and journalistic texts demonstrating that ‘marzipan’ has faithfully and consistently been produced in many different parts of the province of Toledo according to traditional methods.

The renown of Toledo marzipan is documented in numerous historical, literary and journalistic works, in which marzipan is always linked to the name of the province:

Ramón de Mesonero Romanos (1803-1882) describes marzipan as ‘an ingenious work’ when referring to it in his Escenas matritenses: ‘What can I give my first love which combines sensitivity with the most refined taste to the highest degree? A box of “mazapán de Toledo” I declared enthusiastically, placing one on the table’,

Concepción Arenal (1820-1923) dedicates one of her poems to the ‘Christmas box’: ‘They pay it homage and, by way of tribute, Valencia and Murcia offer limes, carts of oranges, dates and pomegranates, fresh grapes and dried figs. Alicante and Jijona send hard and soft nougat, which pale alongside “Toledo marzipan”. From Malaga come raisins.’,

Leopoldo Alas Ureña (Clarín) (1852-1901). In an article for the magazine ‘Museum’, the author of La Regenta comments on various works by Emilia Pardo Bazán: ‘The entire romance between these two gives the reader a feeling similar to that of eating huevos hilados [sweet egg dish], dried, all day long, or “mazapán de Toledo” tasting of its box, or old sponge cake ...’,

Enrique Gaspar (1842-1902), in his operetta La tribu Salvaje, first staged on 23 May 1901. It is set in a classroom where the children ‘sing’ the multiplication table and the teacher decides to ‘have a little refresher on Spain's politico-physical, industrial and agricultural geography’. This involves the pupils linking each city with its best known distinctive product: ‘Gijon has cider, Toledo, marzipan’,

Benito Perez Galdos (1843-1920) spent long periods in the city of Toledo, which forms the backdrop for some of his novels. Mazapán de Toledo is mentioned twice in El audaz. In Fortunata y Jacinta, we also find various references to ‘mazapán de Toledo’, each time in connection with Christmas preparations. The recognition and renown which ‘mazapán de Toledo’ enjoys today is evident from numerous fiestas and from descriptions in different media, from prestigious gastronomic guides and well known restaurants. The adjectives used to describe ‘mazapán de Toledo’ include: exquisite, classic, typical, extremely famous, ultra-famous and foremost gastronomic speciality. Traditionally, the shop windows of Toledo's best known confectioners are decorated with painstaking reproductions and depictions of religious, heraldic or everyday scenes, using marzipan as the basis. By way of illustration, we have reproduced a photograph of a shop window in Toledo's Santo Tomé Street, where marzipan has been used to recreate an amazingly precise version of the ‘Lions' Gate’ of Toledo Cathedral.

The original recipe and expertise of the master craftsmen traversed the imperial city's walls centuries ago, which is why those parts of the province where the marzipan factories are located also have their own marzipan-related festivities and traditions. Marzipan is traditionally produced in Sonseca, Gálvez, Consuegra, Fuensalida, Polán and other towns.

It is mentioned in the following prestigious gastronomic guides:

Michelin Guide: ‘Toledo's foremost gastronomic speciality is clearly the ultra-famous “mazapán de Toledo”, which is made using almonds and sugar’,

Guía Campsa: ‘Toledo has a large selection of museums, and other exquisite cuisine waiting to be discovered in addition to its famous marzipan’.

It appears in the dessert menus of Toledo's best known restaurants such as Casa Aurelio, Venta de Aires, Adolfo and La Catedral, some of which suggest or recommend as dessert the exquisite‘mazapán de Toledo’.

4.7.   Inspection body:

| Name: | Servicios de Inspección y Certificación, S.L. |
| --- | --- |
| Address: | C/ Ciudad, no 13-1o |
| E-45001 Toledo |

Name:

Servicios de Inspección y Certificación, S.L.

Address:

C/ Ciudad, no 13-1o

E-45001 Toledo

Telephone

(34) 925 28 51 39

Fax

(34) 925 28 51 39

E-mail:

—

The inspection body Servicios de Inspección y Certificación, S.L., as certification body, meets the requirements in standard EN 45011.

4.8.   Labelling: The labelling of the product ‘mazapán de Toledo’ will include a reference to the ‘PROTECTED GEOGRAPHICAL INDICATION MAZAPÁN DE TOLEDO’ and the logo which identifies the inspection body as the certification body for the product.

Products where ‘Mazapán de Toledo PGI’ is the main ingredient may be marketed to consumers in packaging which states Elaborado con Indicación Geográfica Protegida Mazapán de Toledo (Made with Protected Geographical Indication ‘Mazapán de Toledo’) without the Community logo, provided that:

Mazapán de Toledo PGI, certified as such, is the only marzipan paste which has been used in the product, and

the individuals using the words Elaborado con Indicación Geográfica Protegida Mazapán de Toledo are authorised to do so.

In this context, use of the words Elaborado con Indicación Geográfica Protegida Mazapán de Toledo on the products made will be authorised by the Regulatory Council for the Protected Geographical Indication ‘mazapán de Toledo’, as it holds the intellectual property rights conferred by registering the designation Mazapán de Toledo PGI.

The Regulatory Council for the Protected Geographical Indication ‘mazapán de Toledo’ will enter in the relevant registers those users who are authorised to use the words Elaborado con Indicación Geográfica Protegida Mazapán de Toledo and ensure that the protected designation is used correctly.

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(1)  OJ L 93, 31.3.2006, p. 12.

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