# Official Journal C 163/2023

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 163 |
| | |
| English edition | Information and Notices | Volume 668 May 2023 |

ISSN 1977-091X

Official Journal

of the European Union

C 163

English edition

Information and Notices

Volume 668 May 2023

---

| Contents | page |
| --- | --- |
| | I   Resolutions, recommendations and opinions |
| | OPINIONS |
| | European Commission |
| 2023/C 163/01 | Commission Opinion of 5 May 2023 relating to the modified plan for the disposal of radioactive waste arising from the Loviisa low and intermediate level waste repository located at the Loviisa site in Finland | 1 |

Contents

page

I   Resolutions, recommendations and opinions

OPINIONS

European Commission

2023/C 163/01

Commission Opinion of 5 May 2023 relating to the modified plan for the disposal of radioactive waste arising from the Loviisa low and intermediate level waste repository located at the Loviisa site in Finland

1

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| | II   Information |
| --- | --- |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2023/C 163/02 | Non-opposition to a notified concentration (Case M.10840 – INFINIGATE / NUVIAS) (
  1
  ) | 3 |
| 2023/C 163/03 | Non-opposition to a notified concentration (Case M.10759 – GIP / MERIDIAM / VEOLIA (HAZARDOUS WASTE BUSINESS)) (
  1
  ) | 4 |
| 2023/C 163/04 | Non-opposition to a notified concentration (Case M.11034 – OMRON / KIRIN / KTS) (
  1
  ) | 5 |
| 2023/C 163/05 | Non-opposition to a notified concentration (Case M.10891 – BUNGE / SC FRICH ENVOL / SC ONE / BZ GROUP) (
  1
  ) | 6 |
| 2023/C 163/06 | Commission Guidance on the content and structure of the summary of the clinical investigation report (
  1
  ) | 7 |

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2023/C 163/02

Non-opposition to a notified concentration (Case M.10840 – INFINIGATE / NUVIAS) (
  1
  )

1

3

2023/C 163/03

Non-opposition to a notified concentration (Case M.10759 – GIP / MERIDIAM / VEOLIA (HAZARDOUS WASTE BUSINESS)) (
  1
  )

1

4

2023/C 163/04

Non-opposition to a notified concentration (Case M.11034 – OMRON / KIRIN / KTS) (
  1
  )

1

5

2023/C 163/05

Non-opposition to a notified concentration (Case M.10891 – BUNGE / SC FRICH ENVOL / SC ONE / BZ GROUP) (
  1
  )

1

6

2023/C 163/06

Commission Guidance on the content and structure of the summary of the clinical investigation report (
  1
  )

1

7

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2023/C 163/07 | Euro exchange rates – 5 May 2023 | 14 |
| | NOTICES FROM MEMBER STATES |
| 2023/C 163/08 | Commission information notice pursuant to Article 16(4) of Regulation (EC) 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community – Public service obligations in respect of scheduled air services (
  1
  ) | 15 |
| 2023/C 163/09 | Commission information notice pursuant to Article 17(5) of Regulation 1008/2008 of the European parliament and of the Council on common rules for the operation of air services in the Community – Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations (
  1
  ) | 16 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2023/C 163/07

Euro exchange rates – 5 May 2023

14

NOTICES FROM MEMBER STATES

2023/C 163/08

Commission information notice pursuant to Article 16(4) of Regulation (EC) 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community – Public service obligations in respect of scheduled air services (
  1
  )

1

15

2023/C 163/09

Commission information notice pursuant to Article 17(5) of Regulation 1008/2008 of the European parliament and of the Council on common rules for the operation of air services in the Community – Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations (
  1
  )

1

16

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| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2023/C 163/10 | Prior notification of a concentration (Case M.10855 — Capgemini / Orange / JV) (
  1
  ) | 17 |
| 2023/C 163/11 | Prior notification of a concentration (Case M.11059 – TOYOFUJI / NYK / Kamigumi / TTC / PT. Patimban) – Candidate case for simplified procedure (
  1
  ) | 19 |
| | OTHER ACTS |
| | European Commission |
| 2023/C 163/12 | Publication of an application for approval of an amendment, which is not minor, to a product specification pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs | 21 |
| 2023/C 163/13 | Publication of an approved standard amendment to the product specification of a protected designation of origin or protected geographical indication in the agricultural products and foodstuffs sector, as referred to in Article 6b(2) and (3) of Commission Delegated Regulation (EU) No 664/2014 | 33 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2023/C 163/10

Prior notification of a concentration (Case M.10855 — Capgemini / Orange / JV) (
  1
  )

1

17

2023/C 163/11

Prior notification of a concentration (Case M.11059 – TOYOFUJI / NYK / Kamigumi / TTC / PT. Patimban) – Candidate case for simplified procedure (
  1
  )

1

19

OTHER ACTS

European Commission

2023/C 163/12

Publication of an application for approval of an amendment, which is not minor, to a product specification pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

21

2023/C 163/13

Publication of an approved standard amendment to the product specification of a protected designation of origin or protected geographical indication in the agricultural products and foodstuffs sector, as referred to in Article 6b(2) and (3) of Commission Delegated Regulation (EU) No 664/2014

33

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

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(1)   Text with EEA relevance.

1

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

EN

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I Resolutions, recommendations and opinions

OPINIONS

European Commission

| 8.5.2023 | EN | Official Journal of the European Union | C 163/1 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/1

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COMMISSION OPINION

of 5 May 2023

relating to the modified plan for the disposal of radioactive waste arising from the Loviisa low and intermediate level waste repository located at the Loviisa site in Finland

(Only the Finnish and Swedish texts are authentic)

(2023/C 163/01)

The assessment below is carried out under the provisions of Article 37 of the Euratom Treaty, without prejudice to any additional assessments to be carried out under the Treaty on the Functioning of the European Union and the obligations stemming from it and from secondary legislation (1).

On 3 October 2022, the European Commission received from the Government of Finland, in accordance with Article 37 of the Euratom Treaty, the General Data relating to the modified plan for the disposal of radioactive waste (2) arising from the Loviisa low and intermediate level waste repository. The submission includes the new construction in the repository for the disposal of the decommissioning waste from the Loviisa power plant, and small amounts of radioactive waste generated elsewhere in Finland.

On the basis of these data and additional information requested by the Commission on 8 December 2022 and provided by the Finnish authorities on 1 February 2023, and following consultation with the Group of Experts, the Commission has drawn up the following opinion:

| 1. | The distance from the site to the nearest border of another Member State, in this case Estonia is 58 km. The distance to the Russian Federation is 45 km. |
| --- | --- |

1.

The distance from the site to the nearest border of another Member State, in this case Estonia is 58 km. The distance to the Russian Federation is 45 km.

| 2. | During the operational period of the disposal facility:
  The modified plan still envisages that radioactive waste will be emplaced without intention of retrieval.
  Under normal operating conditions the repository will release neither airborne nor liquid radioactive effluents.
  In the event of unplanned releases of radioactive effluents which may follow an accident of the type and magnitude considered in the modified plan, these releases are not liable to result in a radioactive contamination of the water, soil or airspace of another Member State or a neighbouring country which is significant from the point of view of health, in compliance with the provisions of the Basic Safety Standards Directive (3). |
| --- | --- |

2.

During the operational period of the disposal facility:

The modified plan still envisages that radioactive waste will be emplaced without intention of retrieval.

Under normal operating conditions the repository will release neither airborne nor liquid radioactive effluents.

In the event of unplanned releases of radioactive effluents which may follow an accident of the type and magnitude considered in the modified plan, these releases are not liable to result in a radioactive contamination of the water, soil or airspace of another Member State or a neighbouring country which is significant from the point of view of health, in compliance with the provisions of the Basic Safety Standards Directive (3).

| 3. | Beyond the operational period of the disposal facility:
  The measures envisaged, in the modified plan, for the final closure of the repository as described in the General Data provide assurance that the conclusions under point 2 above will remain valid in the long term.
  In conclusion, the Commission is of the opinion that the implementation of the modified plan for the disposal of radioactive waste in whatever form arising from the Loviisa low and intermediate level waste repository, located at the Loviisa site in Finland, during its normal operational life and after its final closure, as well as in the event of accidents of the type and magnitude considered in the General Data, is not liable to result in a radioactive contamination, significant from the point of view of health, of the water, soil or airspace of another Member State or a neighbouring country, in respect of the provisions laid down in the Basic Safety Standards. |
| --- | --- |

3.

Beyond the operational period of the disposal facility:

The measures envisaged, in the modified plan, for the final closure of the repository as described in the General Data provide assurance that the conclusions under point 2 above will remain valid in the long term.

In conclusion, the Commission is of the opinion that the implementation of the modified plan for the disposal of radioactive waste in whatever form arising from the Loviisa low and intermediate level waste repository, located at the Loviisa site in Finland, during its normal operational life and after its final closure, as well as in the event of accidents of the type and magnitude considered in the General Data, is not liable to result in a radioactive contamination, significant from the point of view of health, of the water, soil or airspace of another Member State or a neighbouring country, in respect of the provisions laid down in the Basic Safety Standards.

Done at Brussels, 5 May 2023.

For the Commission

Kadri SIMSON

Member of the Commission

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(1)  For instance, under the Treaty on the Functioning of the European Union, environmental aspects should be further assessed. Indicatively, the Commission would like to draw attention to the provisions of Directive 2011/92/EU on the assessment of the effects of certain public and private projects on the environment, as amended by Directive 2014/52/EU; to Directive 2001/42/EC on the assessment of the effects of certain plans and programmes on the environment, as well as to Directive 92/43/EEC on the conservation of natural habitats and of wild fauna and flora and to Directive 2000/60/EC establishing a framework for Community action in the field of water policy.

1

(2)  The disposal of radioactive waste in the meaning of point 1 of Commission Recommendation 2010/635/Euratom of 11 October 2010 on the application of Article 37 of the Euratom Treaty (OJ L 279, 23.10.2010, p. 36).

2

(3)  Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).

3

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 8.5.2023 | EN | Official Journal of the European Union | C 163/3 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/3

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Non-opposition to a notified concentration

(Case M.10840 – INFINIGATE / NUVIAS)

(Text with EEA relevance)

(2023/C 163/02)

On 20 October 2022, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). 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:

| — | in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/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 (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32022M10840. EUR-Lex is the online point of access to European Union law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32022M10840. EUR-Lex is the online point of access to European Union law.

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

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| 8.5.2023 | EN | Official Journal of the European Union | C 163/4 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/4

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Non-opposition to a notified concentration

(Case M.10759 – GIP / MERIDIAM / VEOLIA (HAZARDOUS WASTE BUSINESS))

(Text with EEA relevance)

(2023/C 163/03)

On 28 October 2022, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in French and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/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 (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32022M10759. EUR-Lex is the online point of access to European Union law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32022M10759. EUR-Lex is the online point of access to European Union law.

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

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| 8.5.2023 | EN | Official Journal of the European Union | C 163/5 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/5

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Non-opposition to a notified concentration

(Case M.11034 – OMRON / KIRIN / KTS)

(Text with EEA relevance)

(2023/C 163/04)

On 14 February 2023, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). 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:

| — | in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/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 (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32023M11034. EUR-Lex is the online point of access to European Union law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32023M11034. EUR-Lex is the online point of access to European Union law.

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

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| 8.5.2023 | EN | Official Journal of the European Union | C 163/6 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/6

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Non-opposition to a notified concentration

(Case M.10891 – BUNGE / SC FRICH ENVOL / SC ONE / BZ GROUP)

(Text with EEA relevance)

(2023/C 163/05)

On 20 March 2023, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). 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:

| — | in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/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 (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32023M10891. EUR-Lex is the online point of access to European Union law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32023M10891. EUR-Lex is the online point of access to European Union law.

---

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

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| 8.5.2023 | EN | Official Journal of the European Union | C 163/7 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/7

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COMMISSION GUIDANCE

on the content and structure of the summary of the clinical investigation report

(Text with EEA relevance)

(2023/C 163/06)

Table of Contents

| 1. | Introduction | 8 |
| --- | --- | --- |

1.

| 2. | The summary of the clinical investigation report | 8 |
| --- | --- | --- |

2.

| 3. | Revision clause | 12 |
| --- | --- | --- |

3.

| 4. | Glossary and abbreviations | 12 |
| --- | --- | --- |

4.

| 5. | References | 12 |
| --- | --- | --- |

5.

1.   Introduction

This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary of the clinical investigation report.

This guidance aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.1

According to Article 77 (5) of the MDR, the sponsor of a clinical investigation shall submit a report of the clinical investigation within one year of the end of the clinical investigation or within three months of the early termination and this report shall be accompanied by a summary. The minimum requirements of the clinical investigation report are outlined in Section 7, Chapter III of Annex XV of the MDR. Section 7, Chapter III of Annex XV of the MDR also outlines what will be covered by the summary, namely:

| — | Title of the clinical investigation |
| --- | --- |

—

Title of the clinical investigation

| — | Purpose of the clinical investigation |
| --- | --- |

—

Purpose of the clinical investigation

| — | Description of the investigation, investigational design and methods used |
| --- | --- |

—

Description of the investigation, investigational design and methods used

| — | Results of the investigation |
| --- | --- |

—

Results of the investigation

| — | Conclusion of the investigation |
| --- | --- |

—

Conclusion of the investigation

According to Article 77(5) of the MDR, the report and summary shall be submitted to Member States in which the clinical investigation was conducted by means of the electronic system referred to in Article 73 of the MDR. According to Article 77(7) of the MDR, the report and the summary shall become publicly accessible through the electronic system referred to in Article 73 of the MDR, at the latest when the device is registered in accordance with Article 29 of the MDR and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission.

2.   The summary of the clinical investigation report

Explanatory note

| — | This is a summary document. Only relevant information should be supplied. Where a ‘brief description’ is requested be as concise as possible. Avoid simply copying bodies of text from the full clinical investigation report. |
| --- | --- |

—

This is a summary document. Only relevant information should be supplied. Where a ‘brief description’ is requested be as concise as possible. Avoid simply copying bodies of text from the full clinical investigation report.

| — | The language used must be appropriate for the intended user(s) of the device. Their levels of health literacy and numeracy should be considered at all times when developing this summary document. |
| --- | --- |

—

The language used must be appropriate for the intended user(s) of the device. Their levels of health literacy and numeracy should be considered at all times when developing this summary document.

| — | Ensure no promotional content is included in this document. |
| --- | --- |

—

Ensure no promotional content is included in this document.

2.1.   Cover page

| Date of summary: | |
| --- | --- |
| Title of clinical investigation: | |
| Name and contact details of the entity sponsoring the study: | |
| Name of the entity funding the study2: | |
| Single identification number: | Prior to full functioning of EUDAMED, this will be the CIV-ID, which is obtained from the authorising competent authority.


  Once EUDAMED is functional, this refers to the single identification number as referred to in Article 70(1) of MDR |
| Clinical investigation plan number: | |

Date of summary:

Title of clinical investigation:

Name and contact details of the entity sponsoring the study:

Name of the entity funding the study2:

Single identification number:

Prior to full functioning of EUDAMED, this will be the CIV-ID, which is obtained from the authorising competent authority.

Once EUDAMED is functional, this refers to the single identification number as referred to in Article 70(1) of MDR

Clinical investigation plan number:

2.2.   Content and structure of the summary of the clinical investigation report

| Title of the clinical investigation - summary information4 |
| --- |
| Brief Study Title | |
| Full study title3 | A brief description of the design, the experimental medical device, comparator (when relevant), care provider (when relevant), and population of the clinical investigation. |
| Dates of investigation3 | Start (the first act of recruitment in the clinical investigation) and end (the last visit of the last subject in the clinical investigation) dates of the clinical investigation5. Please see MDCG document 2021-6 for further description of these terms. |
| Location(s) | Where the investigation was conducted, including site location and country. |
| If relevant, reason for temporary halt or early termination3 | Where relevant. Reasons may include positive active findings, positive control findings, safety findings, futility, slow recruitment, external evidence, etc.2 |

Title of the clinical investigation - summary information4

Brief Study Title

Full study title3

A brief description of the design, the experimental medical device, comparator (when relevant), care provider (when relevant), and population of the clinical investigation.

Dates of investigation3

Start (the first act of recruitment in the clinical investigation) and end (the last visit of the last subject in the clinical investigation) dates of the clinical investigation5. Please see MDCG document 2021-6 for further description of these terms.

Location(s)

Where the investigation was conducted, including site location and country.

If relevant, reason for temporary halt or early termination3

Where relevant. Reasons may include positive active findings, positive control findings, safety findings, futility, slow recruitment, external evidence, etc.2

| Purpose of the clinical investigation4 |
| --- |
| Brief explanation of the rationale for the clinical investigation, including:







  — | basic background information about the device to be studied |

Purpose of the clinical investigation4

Brief explanation of the rationale for the clinical investigation, including:

—

basic background information about the device to be studied

| — | the condition being treated |
| --- | --- |

—

the condition being treated

Depending on the context of the clinical investigation, please describe:

| — | current standard of care |
| --- | --- |

—

current standard of care

| — | other possible interventions |
| --- | --- |

—

other possible interventions

| Description of the investigational device, clinical investigation, and methods used4 |
| --- |
| Do not include any results, analysis, conclusions or discussion points in this section. |
| Description of participants4 | Description of the eligibility criteria for participants and the settings.


  Where applicable, a description of the eligibility criteria for centres involved in the investigation and those performing the interventions. |
| Description of the device and comparator6 | Should include a description of the investigational device, its version/variant and intended purpose including the different components required for the medical intervention(s) involving the device under investigation (e.g. the pre and post-operative care, medical/surgical intervention, etc.).


  For comparative studies, descriptions of both the experimental intervention and comparator should be provided. |
| Description of procedures to use the device9 | Brief description of the procedures and methods necessary for use of the device in the clinical investigation. |
| Study Design4 | Description and justification of the chosen study design, i.e. randomised controlled trial (parallel, cluster, crossover, factorial, non-inferiority), non-randomised comparative study, non-comparative study, other. |
| Objectives and endpoints 4 | Brief description clearly stating the primary and secondary objectives of the investigation as well as hypotheses that were tested.


  Primary and secondary endpoints should also be clearly defined. |
| Sample size 7 | Please include the power and sample size estimations. Include adjustments made in this calculation for dropout rate/lost to follow up, where relevant.10 |
| Randomisation and blinding8 | Where relevant, a description of the methods of intervention allocation and blinding methods used (if any). |
| Follow up duration4 | Length of time participants were followed in the study. Also indicate the intended lifetime of the device under investigation. |
| Concomitant treatments4 | Description of any treatments that were necessary for all subjects receiving the medical device in this clinical investigation. Please explain how this may differ from usual standard of care for this medical device, if relevant. |
| Statistical analysis methods4 | Brief description of the statistical methods used to provide outcomes’ estimates, compare groups for the primary outcome, to perform additional analyses, to adjust for biases, to deal with missing data. |
| Substantial modifications11 | Where relevant, a table describing any substantial modifications to the clinical investigation plan, relevant versions of the clinical investigation plan and dates of these modifications. Please confirm approval from an ethics committee has been received for these modifications. |

Description of the investigational device, clinical investigation, and methods used4

Do not include any results, analysis, conclusions or discussion points in this section.

Description of participants4

Description of the eligibility criteria for participants and the settings.

Where applicable, a description of the eligibility criteria for centres involved in the investigation and those performing the interventions.

Description of the device and comparator6

Should include a description of the investigational device, its version/variant and intended purpose including the different components required for the medical intervention(s) involving the device under investigation (e.g. the pre and post-operative care, medical/surgical intervention, etc.).

For comparative studies, descriptions of both the experimental intervention and comparator should be provided.

Description of procedures to use the device9

Brief description of the procedures and methods necessary for use of the device in the clinical investigation.

Study Design4

Description and justification of the chosen study design, i.e. randomised controlled trial (parallel, cluster, crossover, factorial, non-inferiority), non-randomised comparative study, non-comparative study, other.

Objectives and endpoints 4

Brief description clearly stating the primary and secondary objectives of the investigation as well as hypotheses that were tested.

Primary and secondary endpoints should also be clearly defined.

Sample size 7

Please include the power and sample size estimations. Include adjustments made in this calculation for dropout rate/lost to follow up, where relevant.10

Randomisation and blinding8

Where relevant, a description of the methods of intervention allocation and blinding methods used (if any).

Follow up duration4

Length of time participants were followed in the study. Also indicate the intended lifetime of the device under investigation.

Concomitant treatments4

Description of any treatments that were necessary for all subjects receiving the medical device in this clinical investigation. Please explain how this may differ from usual standard of care for this medical device, if relevant.

Statistical analysis methods4

Brief description of the statistical methods used to provide outcomes’ estimates, compare groups for the primary outcome, to perform additional analyses, to adjust for biases, to deal with missing data.

Substantial modifications11

Where relevant, a table describing any substantial modifications to the clinical investigation plan, relevant versions of the clinical investigation plan and dates of these modifications. Please confirm approval from an ethics committee has been received for these modifications.

| Results of the investigation4 |
| --- |
| Participant flow12 | Number of participants screened, enrolled, allocated and followed up to each intervention.


  The use of this or similar flowchart is strongly recommended13.


  Please note, the below flowchart is for randomised two arm studies. The flowchart will need to be adjusted for different study designs. |
| Baseline demographic and clinical characteristics4 | If available, description of age, sex, ethnic background, country, stage of disease, relevant co-morbidities and any other disease-influencing factors in participants.


  When applicable, description of care providers (case volume, qualification, expertise, etc.) and centres (volume) in each group. |
| Outcome of the intervention4 | Results on primary endpoint including in absolute numbers when feasible (e.g. 10/20, not 50 %), estimated effect size and the precision of the result. Please include whether an analysis is intention-to-treat or per protocol.


  Results of secondary endpoints or additional analyses can be reported, but the dangers of drawing conclusions from these results should be discussed. |
| Safety outcomes 14 | Description of adverse events15, adverse device effects16 and device deficiencies15Listed table in order of most to least frequent, in numerical absolute numbers (X out of YX subjects) and percentage (X% of subjects) and the nature of these events/effects (expected/unexpected).


  Only aggregated information related to these events/effects should be presented.5List of any subject deaths.


  Number of subjects withdrawn from the investigation and reasons. |
| Deviations to clinical investigation plan5 | Where relevant, a description of any deviations to the clinical investigation plan which occurred during the clinical investigation |

Results of the investigation4

Participant flow12

Number of participants screened, enrolled, allocated and followed up to each intervention.

The use of this or similar flowchart is strongly recommended13.

Please note, the below flowchart is for randomised two arm studies. The flowchart will need to be adjusted for different study designs.

Image 1

Baseline demographic and clinical characteristics4

If available, description of age, sex, ethnic background, country, stage of disease, relevant co-morbidities and any other disease-influencing factors in participants.

When applicable, description of care providers (case volume, qualification, expertise, etc.) and centres (volume) in each group.

Outcome of the intervention4

Results on primary endpoint including in absolute numbers when feasible (e.g. 10/20, not 50 %), estimated effect size and the precision of the result. Please include whether an analysis is intention-to-treat or per protocol.

Results of secondary endpoints or additional analyses can be reported, but the dangers of drawing conclusions from these results should be discussed.

Safety outcomes 14

Description of adverse events15, adverse device effects16 and device deficiencies15Listed table in order of most to least frequent, in numerical absolute numbers (X out of YX subjects) and percentage (X% of subjects) and the nature of these events/effects (expected/unexpected).

Only aggregated information related to these events/effects should be presented.5List of any subject deaths.

Number of subjects withdrawn from the investigation and reasons.

Deviations to clinical investigation plan5

Where relevant, a description of any deviations to the clinical investigation plan which occurred during the clinical investigation

| Conclusion of the clinical investigation4 |
| --- |
| What the results mean17 | Brief description of the results of this investigation: overall assessment of benefits vs risks of the intervention in light of the investigation


  What does this clinical investigation add to the clinical data related to the safety and performance of the device? |
| What do the results add to the current scientific knowledge17 | Brief description of the results of this investigation in the context of current evidence: overall benefits vs risks assessment of the investigational medical device in the context of all other evidence available, and the implications of the results in clinical practice. |
| Limitations18 | Any limitations of the investigation, such as biases in the investigation, uncertainties which remain following the investigation or limitations in the applicability of the results to real world settings |
| Potential for future studies18 | |

Conclusion of the clinical investigation4

What the results mean17

Brief description of the results of this investigation: overall assessment of benefits vs risks of the intervention in light of the investigation

What does this clinical investigation add to the clinical data related to the safety and performance of the device?

What do the results add to the current scientific knowledge17

Brief description of the results of this investigation in the context of current evidence: overall benefits vs risks assessment of the investigational medical device in the context of all other evidence available, and the implications of the results in clinical practice.

Limitations18

Any limitations of the investigation, such as biases in the investigation, uncertainties which remain following the investigation or limitations in the applicability of the results to real world settings

Potential for future studies18

3.   Revision clause

Based on the experience gained through the application of these guidelines, the Commission may consider revising this document.

4.   Glossary and abbreviations

| CIV-ID | Clinical Investigation Identification (number) |
| --- | --- |
| EUDAMED | European Database for Medical Devices |
| MDR | Medical Device Regulation |

CIV-ID

Clinical Investigation Identification (number)

EUDAMED

European Database for Medical Devices

MDR

Medical Device Regulation

5.   References

| 1. | Regulation (EU) 2017/745 Article 77 (5) |
| --- | --- |

1.

Regulation (EU) 2017/745 Article 77 (5)

| 2. | The funding entity is the entity which provides financing for the clinical investigation, as per the reference to finance in Regulation (EU) 745/2017 Annex XV, Chapter II, Section 3.1.4 |
| --- | --- |

2.

The funding entity is the entity which provides financing for the clinical investigation, as per the reference to finance in Regulation (EU) 745/2017 Annex XV, Chapter II, Section 3.1.4

| 3. | Regulation (EU) 2017/745 Article 77 |
| --- | --- |

3.

Regulation (EU) 2017/745 Article 77

| 4. | Regulation (EU) 2017/745 Annex XV, Chapter III, Section 7 |
| --- | --- |

4.

Regulation (EU) 2017/745 Annex XV, Chapter III, Section 7

| 5. | MDCG guidance document 2021-6: Questions & Answers regarding clinical investigation |
| --- | --- |

5.

MDCG guidance document 2021-6: Questions & Answers regarding clinical investigation

| 6. | Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.2 |
| --- | --- |

6.

Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.2

| 7. | Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.3 |
| --- | --- |

7.

Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.3

| 8. | Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.4 |
| --- | --- |

8.

Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.4

| 9. | Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.5 |
| --- | --- |

9.

Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.6.5

| 10. | Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.7 |
| --- | --- |

10.

Regulation (EU) 2017/745 Annex XV, Chapter II, Section 3.7

| 11. | ‘Substantial modification’ as described in MDCG guidance document 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation |
| --- | --- |

11.

‘Substantial modification’ as described in MDCG guidance document 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation

| 12. | Adapted from Regulation (EU) 2017/745 Annex XV, Chapter III, Section 7 and International standard EN ISO 14155:2020 Annex D.7 |
| --- | --- |

12.

Adapted from Regulation (EU) 2017/745 Annex XV, Chapter III, Section 7 and International standard EN ISO 14155:2020 Annex D.7

| 13. | Modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment. Isabelle Boutron, MD, PhD; et al for the CONSORT Group: Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann Intern Med. 2008;148:295-309. |
| --- | --- |

13.

Modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment. Isabelle Boutron, MD, PhD; et al for the CONSORT Group: Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann Intern Med. 2008;148:295-309.

| 14. | Regulation (EU) 2017/745 Article 80 |
| --- | --- |

14.

Regulation (EU) 2017/745 Article 80

| 15. | Regulation (EU) 2017/745 Article 2 |
| --- | --- |

15.

Regulation (EU) 2017/745 Article 2

| 16. | Regulation (EU) 2017/745 Annex XV, Chapter II, Section 2.5 |
| --- | --- |

16.

Regulation (EU) 2017/745 Annex XV, Chapter II, Section 2.5

| 17. | Adapted from Regulation (EU) 2017/745 Annex XV, Chapter III, Section 7 and International standard ISO 14155:2020 Annex D.8 |
| --- | --- |

17.

Adapted from Regulation (EU) 2017/745 Annex XV, Chapter III, Section 7 and International standard ISO 14155:2020 Annex D.8

| 18. | International standard ISO 14155:2020 Annex D.8 |
| --- | --- |

18.

International standard ISO 14155:2020 Annex D.8

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 8.5.2023 | EN | Official Journal of the European Union | C 163/14 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/14

---

Euro exchange rates (1)

5 May 2023

(2023/C 163/07)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,1014 |
| JPY | Japanese yen | 147,80 |
| DKK | Danish krone | 7,4499 |
| GBP | Pound sterling | 0,87378 |
| SEK | Swedish krona | 11,2365 |
| CHF | Swiss franc | 0,9828 |
| ISK | Iceland króna | 150,10 |
| NOK | Norwegian krone | 11,6895 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 23,401 |
| HUF | Hungarian forint | 372,48 |
| PLN | Polish zloty | 4,5770 |
| RON | Romanian leu | 4,9280 |
| TRY | Turkish lira | 21,4745 |
| AUD | Australian dollar | 1,6379 |
| CAD | Canadian dollar | 1,4860 |
| HKD | Hong Kong dollar | 8,6434 |
| NZD | New Zealand dollar | 1,7488 |
| SGD | Singapore dollar | 1,4600 |
| KRW | South Korean won | 1 451,90 |
| ZAR | South African rand | 20,2345 |
| CNY | Chinese yuan renminbi | 7,6112 |
| IDR | Indonesian rupiah | 16 156,49 |
| MYR | Malaysian ringgit | 4,8869 |
| PHP | Philippine peso | 60,830 |
| RUB | Russian rouble | |
| THB | Thai baht | 37,172 |
| BRL | Brazilian real | 5,4960 |
| MXN | Mexican peso | 19,7073 |
| INR | Indian rupee | 90,0010 |

Currency

Exchange rate

USD

US dollar

1,1014

JPY

Japanese yen

147,80

DKK

Danish krone

7,4499

GBP

Pound sterling

0,87378

SEK

Swedish krona

11,2365

CHF

Swiss franc

0,9828

ISK

Iceland króna

150,10

NOK

Norwegian krone

11,6895

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

23,401

HUF

Hungarian forint

372,48

PLN

Polish zloty

4,5770

RON

Romanian leu

4,9280

TRY

Turkish lira

21,4745

AUD

Australian dollar

1,6379

CAD

Canadian dollar

1,4860

HKD

Hong Kong dollar

8,6434

NZD

New Zealand dollar

1,7488

SGD

Singapore dollar

1,4600

KRW

South Korean won

1 451,90

ZAR

South African rand

20,2345

CNY

Chinese yuan renminbi

7,6112

IDR

Indonesian rupiah

16 156,49

MYR

Malaysian ringgit

4,8869

PHP

Philippine peso

60,830

RUB

Russian rouble

THB

Thai baht

37,172

BRL

Brazilian real

5,4960

MXN

Mexican peso

19,7073

INR

Indian rupee

90,0010

---

(1)  Source: reference exchange rate published by the ECB.

---

NOTICES FROM MEMBER STATES

| 8.5.2023 | EN | Official Journal of the European Union | C 163/15 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/15

---

Commission information notice pursuant to Article 16(4) of Regulation (EC) 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community

Public service obligations in respect of scheduled air services

(Text with EEA relevance)

(2023/C 163/08)

| Member State | Italy |
| --- | --- |
| Routes concerned | Trieste – Milano Linate and vice versa |
| Date of entry into force of the public service obligations | 1 September 2023 |
| Address where the text and any information and/or documentation relating to the public service obligations can be obtained | For more information please contact:





  Ministry of Infrastructure and Transport |
| Department of Sustainable Mobility |
| Directorate-General for Airports, Air Transport and Satellite Services |
| Via Giuseppe Caraci, 36 |
| 00157 Roma |
| ITALIA |

Member State

Italy

Routes concerned

Trieste – Milano Linate and vice versa

Date of entry into force of the public service obligations

1 September 2023

Address where the text and any information and/or documentation relating to the public service obligations can be obtained

For more information please contact:

Ministry of Infrastructure and Transport

Department of Sustainable Mobility

Directorate-General for Airports, Air Transport and Satellite Services

Via Giuseppe Caraci, 36

00157 Roma

ITALIA

Tel. +39 0644127190

| ENAC |
| --- |
| Air Transport and Licensing Department |
| Viale Castro Pretorio, n. 118 |
| 00185 Roma |
| ITALIA |

ENAC

Air Transport and Licensing Department

Viale Castro Pretorio, n. 118

00185 Roma

ITALIA

Tel. +39 0644596532

Internet: http://www.mit.gov.it

http://www.enac.gov.it

Email: dg.ta@pec.mit.gov.it

osp@enac.gov.it

---

| 8.5.2023 | EN | Official Journal of the European Union | C 163/16 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/16

---

Commission information notice pursuant to Article 17(5) of Regulation 1008/2008 of the European parliament and of the Council on common rules for the operation of air services in the Community

Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations

(Text with EEA relevance)

(2023/C 163/09)

| Member State | Italy |
| --- | --- |
| Concerned routes | Trieste – Milano Linate and vice versa |
| Period of validity of the contract | 1 September 2023 – 30 August 2026 |
| Deadline for submission of tenders | 2 months from the date of publication of this notice |
| Address where the text of the invitation to tender and any relevant information and/or documentation related to the public tender and the modified public service obligations can be obtained | ENAC |
| Air Transport and Licensing Department |
| Viale Castro Pretorio, n. 118 |
| 00185 Roma |
| ITALIA |

Member State

Italy

Concerned routes

Trieste – Milano Linate and vice versa

Period of validity of the contract

1 September 2023 – 30 August 2026

Deadline for submission of tenders

2 months from the date of publication of this notice

Address where the text of the invitation to tender and any relevant information and/or documentation related to the public tender and the modified public service obligations can be obtained

ENAC

Air Transport and Licensing Department

Viale Castro Pretorio, n. 118

00185 Roma

ITALIA

Tel. +39 0644596247

Email: osp@enac.gov.it

Internet: http://www.mit.gov.it

http://www.enac.gov.it

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 8.5.2023 | EN | Official Journal of the European Union | C 163/17 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/17

---

Prior notification of a concentration

(Case M.10855 — Capgemini / Orange / JV)

(Text with EEA relevance)

(2023/C 163/10)

1.

This notification concerns the following undertakings:

| — | Capgemini S.E. (‘Capgemini’, France), and; |
| --- | --- |

—

Capgemini S.E. (‘Capgemini’, France), and;

| — | Orange S.A. (‘Orange’, France). |
| --- | --- |

—

Orange S.A. (‘Orange’, France).

Capgemini and Orange will establish a joint-venture (‘Bleu’, France) in which they will acquire joint control within the meaning of Articles 3(1)(b) and 3(4) of the Merger Regulation.

The concentration is accomplished by way of purchase of shares.

2.

| — | Capgemini is active in the areas of strategy and transformation, applications and technology, engineering and operations in 50 countries, and provides IT services to develop, extend, secure and manage the IT infrastructure systems and digital environments of major companies and organizations; |
| --- | --- |

—

Capgemini is active in the areas of strategy and transformation, applications and technology, engineering and operations in 50 countries, and provides IT services to develop, extend, secure and manage the IT infrastructure systems and digital environments of major companies and organizations;

| — | Orange is an electronic communications operator which provides a wide range of services mainly in the area of fixed-line, internet and mobile telephony as well as IT services in a number of countries worldwide. |
| --- | --- |

—

Orange is an electronic communications operator which provides a wide range of services mainly in the area of fixed-line, internet and mobile telephony as well as IT services in a number of countries worldwide.

| — | Bleu will provide sovereign cloud services compliant with the criteria of the ‘Cloud de Confiance’ label in France (i.e., sovereign cloud services meeting specific security requirements set by the French Cybersecurity Agency) to a specific set of customers. |
| --- | --- |

—

Bleu will provide sovereign cloud services compliant with the criteria of the ‘Cloud de Confiance’ label in France (i.e., sovereign cloud services meeting specific security requirements set by the French Cybersecurity Agency) to a specific set of customers.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.10855 – CAPGEMINI / ORANGE / JV

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

---

| 8.5.2023 | EN | Official Journal of the European Union | C 163/19 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/19

---

Prior notification of a concentration

(Case M.11059 – TOYOFUJI / NYK / Kamigumi / TTC / PT. Patimban)

Candidate case for simplified procedure

(Text with EEA relevance)

(2023/C 163/11)

1.

This notification concerns the following undertakings:

| — | Toyofuji Shipping Co., Ltd (Japan), controlled by Toyota Motor Corporation, |
| --- | --- |

—

Toyofuji Shipping Co., Ltd (Japan), controlled by Toyota Motor Corporation,

| — | Nippon Yusen Kabushiki Kaisha (Japan), |
| --- | --- |

—

Nippon Yusen Kabushiki Kaisha (Japan),

| — | Kamigumi Co., Ltd. (Japan), |
| --- | --- |

—

Kamigumi Co., Ltd. (Japan),

| — | Toyota Tsusho Corporation (Japan). |
| --- | --- |

—

Toyota Tsusho Corporation (Japan).

Toyota Tsusho Corporation, Toyofuji Shipping Co., Ltd, Nippon Yusen Kabushiki Kaisha and Kamigumi Co., Ltd. will acquire within the meaning of Article 3(1)(b) and 3(4) of the Merger Regulation joint control of the whole of PT. Patimban International Car Terminal.

The concentration is accomplished by way of purchase of shares.

2.

| — | Toyofuji Shipping Co., Ltd is Toyota Group's marine transport company, based in Tokai city, Aichi, Japan. It is a roll-on/roll-off shipping company with activities in Asia, North America, Oceania and Europe. |
| --- | --- |

—

Toyofuji Shipping Co., Ltd is Toyota Group's marine transport company, based in Tokai city, Aichi, Japan. It is a roll-on/roll-off shipping company with activities in Asia, North America, Oceania and Europe.

| — | Nippon Yusen Kabushiki Kaisha is a worldwide active Japanese shipping company. The company headquarters are located in Chiyoda, Tokyo, Japan. Through its subsidiaries and affiliated companies, Nippon Yusen Kabushiki Kaisha operates a fleet of container ships, bulk and woodchip carriers, roll-on/roll-off car carriers, LNG carriers, and cruise ships. |
| --- | --- |

—

Nippon Yusen Kabushiki Kaisha is a worldwide active Japanese shipping company. The company headquarters are located in Chiyoda, Tokyo, Japan. Through its subsidiaries and affiliated companies, Nippon Yusen Kabushiki Kaisha operates a fleet of container ships, bulk and woodchip carriers, roll-on/roll-off car carriers, LNG carriers, and cruise ships.

| — | Kamigumi Co., Ltd. provides logistics and transportation services, such as harbor transportation, freight transportation, domestic transportation and international transportation services. It also provides onsite factory services such as loading and unloading of raw materials, materials control, warehouse cargo loading, and heavy cargo transportation. The company is active in Thailand, Malaysia, China, Taiwan, Vietnam, Bangladesh, Singapore, Indonesia, Myanmar, Cambodia, Spain, the United States, and Mexico. It is head quartered in Chuo-ku, Kobe, Japan. |
| --- | --- |

—

Kamigumi Co., Ltd. provides logistics and transportation services, such as harbor transportation, freight transportation, domestic transportation and international transportation services. It also provides onsite factory services such as loading and unloading of raw materials, materials control, warehouse cargo loading, and heavy cargo transportation. The company is active in Thailand, Malaysia, China, Taiwan, Vietnam, Bangladesh, Singapore, Indonesia, Myanmar, Cambodia, Spain, the United States, and Mexico. It is head quartered in Chuo-ku, Kobe, Japan.

| — | Toyota Tsusho Corporation (Japan) is part of the Toyota Group and is active on a global basis in importing and exporting on behalf of the Toyota Group. It is headquartered in Tokyo and Nagoya, Japan. PT. Patimban International Car Terminal is currently a fully-owned subsidiary of Toyota Tsusho Corporation. It is exclusively active in Indonesia where it operates and manages the automobile terminal operation business at the Patimban New International Port in Subang Regency, West Java, Indonesia. PT. Patimban International Car Terminal has been operating such terminal since 17 December 2021 and has no other activities in the Indonesian market. |
| --- | --- |

—

Toyota Tsusho Corporation (Japan) is part of the Toyota Group and is active on a global basis in importing and exporting on behalf of the Toyota Group. It is headquartered in Tokyo and Nagoya, Japan. PT. Patimban International Car Terminal is currently a fully-owned subsidiary of Toyota Tsusho Corporation. It is exclusively active in Indonesia where it operates and manages the automobile terminal operation business at the Patimban New International Port in Subang Regency, West Java, Indonesia. PT. Patimban International Car Terminal has been operating such terminal since 17 December 2021 and has no other activities in the Indonesian market.

3.

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.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.11059 – TOYOFUJI / NYK / KAMIGUMI / TTC / PT. PATIMBAN

Observations can be sent to the Commission by email or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Postal address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

---

OTHER ACTS

European Commission

| 8.5.2023 | EN | Official Journal of the European Union | C 163/21 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/21

---

Publication of an application for approval of an amendment, which is not minor, to a product specification pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

(2023/C 163/12)

This publication confers the right to oppose the amendment application pursuant to Article 51 of Regulation (EU) No 1151/2012 of the European Parliament and of the Council (1) within three months from the date of this publication.

APPLICATION FOR APPROVAL OF A NON-MINOR AMENDMENT TO THE PRODUCT SPECIFICATION OF A PROTECTED DESIGNATION OF ORIGIN/PROTECTED GEOGRAPHICAL INDICATION

Application for approval of an amendment in accordance with the first subparagraph of Article 53(2) of Regulation (EU) No 1151/2012

‘Asparago di Cantello’

EU No: PGI-IT-01267-AM01 – 23.3.2021

PDO ( ) PGI (X)

1.   Applicant group and legitimate interest

ASSOCIAZIONE PER LA PRODUZIONE DELL’ASPARAGO DI CANTELLO E PER IL SUO RICONOSCIMENTO IGP (Association for the production and PGI recognition of ‘Asparago di Cantello’)

Address: Via Turconi, 6 – 21050 Cantello (VA), Italy

Tel. +39 3462273144

Email and certified email address: lepianelle.agri@gmail.com, lepianelle@pec.agritel.it

The association is made up of producers who have requested and obtained PGI recognition and who are subject to monitoring by the inspection body.

2.   Member State or Third Country

Italy

3.   Heading in the product specification affected by the amendment(s)

| ☐ | Name of product |
| --- | --- |

☐

Name of product

| ☒ | Description of the product |
| --- | --- |

☒

Description of the product

| ☐ | Geographical area |
| --- | --- |

☐

Geographical area

| ☐ | Proof of origin |
| --- | --- |

☐

Proof of origin

| ☒ | Method of production |
| --- | --- |

☒

Method of production

| ☒ | Link |
| --- | --- |

☒

Link

| ☒ | Labelling |
| --- | --- |

☒

Labelling

| ☐ | Other [to be specified] |
| --- | --- |

☐

Other [to be specified]

4.   Type of amendment(s)

| ☒ | Amendment to product specification of a registered PDO or PGI not to be qualified as minor in accordance with the third subparagraph of Article 53(2) of Regulation (EU) No 1151/2012. |
| --- | --- |

☒

Amendment to product specification of a registered PDO or PGI not to be qualified as minor in accordance with the third subparagraph of Article 53(2) of Regulation (EU) No 1151/2012.

| ☐ | Amendment to product specification of registered PDO or PGI for which a single document (or equivalent) has not been published not to be qualified as minor in accordance with the third subparagraph of Article 53(2) of Regulation (EU) No 1151/2012. |
| --- | --- |

☐

Amendment to product specification of registered PDO or PGI for which a single document (or equivalent) has not been published not to be qualified as minor in accordance with the third subparagraph of Article 53(2) of Regulation (EU) No 1151/2012.

5.   Amendment(s)

Article 2 Characteristics of the product

| 2.1. | Cultivars
  The cultivars used for the production of ‘Asparago di Cantello’ are Precoce d’Argenteuil and derived hybrids.
  New wording: (Point 2.1 of the single document and point 3.2 of the product specification have been amended.) |
| --- | --- |

2.1.

The cultivars used for the production of ‘Asparago di Cantello’ are Precoce d’Argenteuil and derived hybrids.

New wording: (Point 2.1 of the single document and point 3.2 of the product specification have been amended.)

| 2.1. | Cultivars
  The cultivars used for the production of ‘Asparago di Cantello’ are Precoce d’Argenteuil and its derived hybrids and other asparagus cultivars, such as Grolim, Zeno, Cumulus, Vitalim, Giove, Vittorio, Eros, Franco, Fruhlim, Magnus, Herkolim and Terralim, that are suited to the production of white asparagus with the characteristics set out in the product specification.
  Reason:

  For the production of ‘Asparago di Cantello’ it is permitted to use other asparagus cultivars that nurseries make available on the market on a regular basis and which the growers, based on experience, consider suitable for their growing traditions and for developing the morphological and organoleptic characteristics set out in the product specification. The growers diversify their choice of cultivars to be able to better plan the harvest and extend the harvesting period, which increases the crop’s economic viability. Also, they choose improved cultivars that are better able to resist adverse weather conditions, thus reducing the use of plant protection products, which ultimately makes the product healthier. The main condition, however, is that the specification’s requirements regarding the characteristics of the product – which have earned it its reputation over the years – must be met to ensure that it passes the relevant checks. Along with tradition, there have been constant improvements in the production process as growing techniques have developed and improved cultivars, derived from those traditionally used, have become available. When planting new asparagus plots, the growers will choose the cultivars which, in their experience, are best adapted to the soil and climate conditions and best suited to bringing out the characteristics that distinguish ‘Asparago di Cantello’. |
| --- | --- |

2.1.

The cultivars used for the production of ‘Asparago di Cantello’ are Precoce d’Argenteuil and its derived hybrids and other asparagus cultivars, such as Grolim, Zeno, Cumulus, Vitalim, Giove, Vittorio, Eros, Franco, Fruhlim, Magnus, Herkolim and Terralim, that are suited to the production of white asparagus with the characteristics set out in the product specification.

Reason:

For the production of ‘Asparago di Cantello’ it is permitted to use other asparagus cultivars that nurseries make available on the market on a regular basis and which the growers, based on experience, consider suitable for their growing traditions and for developing the morphological and organoleptic characteristics set out in the product specification. The growers diversify their choice of cultivars to be able to better plan the harvest and extend the harvesting period, which increases the crop’s economic viability. Also, they choose improved cultivars that are better able to resist adverse weather conditions, thus reducing the use of plant protection products, which ultimately makes the product healthier. The main condition, however, is that the specification’s requirements regarding the characteristics of the product – which have earned it its reputation over the years – must be met to ensure that it passes the relevant checks. Along with tradition, there have been constant improvements in the production process as growing techniques have developed and improved cultivars, derived from those traditionally used, have become available. When planting new asparagus plots, the growers will choose the cultivars which, in their experience, are best adapted to the soil and climate conditions and best suited to bringing out the characteristics that distinguish ‘Asparago di Cantello’.

| 2.2. | Characteristics of the product
  Morphological characteristics
  ‘Asparago di Cantello’, which must not exceed 22 cm in length, is classified into two quality classes based on the diameter of the shoot (measured at the middle):






  — | Extra: diameter of the shoot between 21 and 25 mm. |
| --- | --- | --- |

2.2.

Morphological characteristics

‘Asparago di Cantello’, which must not exceed 22 cm in length, is classified into two quality classes based on the diameter of the shoot (measured at the middle):

—

Extra: diameter of the shoot between 21 and 25 mm.

| — | Class I: diameter of the shoot between 13 and 20 mm. |
| --- | --- |

—

Class I: diameter of the shoot between 13 and 20 mm.

In each individual pack within the above classes there is a 10 % margin of tolerance, in terms of weight, for shoots not meeting the required size.

Organoleptic and chemical-physical characteristics

The organoleptic analysis produced the following results:

Aroma: intense but delicate overall, with no foreign odours;

Taste: sweet, intense, with a slightly bitter aftertaste; Asparagus aroma: medium to strong.

New wording: (Point 2.2 of the single document and point 3.2 of the product specification have been amended.)

| 2. | Characteristics of the product
  Morphological characteristics
  ‘Asparago di Cantello’, which must not exceed 22 cm in length, is classified into the following three UNECE quality classes based on the diameter of the shoot:






  — | Extra: (minimum diameter: 12 mm and above) |
| --- | --- | --- |

2.

Morphological characteristics

‘Asparago di Cantello’, which must not exceed 22 cm in length, is classified into the following three UNECE quality classes based on the diameter of the shoot:

—

Extra: (minimum diameter: 12 mm and above)

| — | Class I: (minimum diameter: 10 mm) |
| --- | --- |

—

Class I: (minimum diameter: 10 mm)

| — | Class II: (minimum diameter: 8 mm). |
| --- | --- |

—

Class II: (minimum diameter: 8 mm).

In each individual pack within the same class there is a margin of tolerance, in terms of weight, of 10 % for Class I and Class II and 5 % for Extra for shoots not meeting the required size.

Organoleptic and chemical-physical characteristics

The organoleptic analysis produced the following results:

| — | Aroma: intense but delicate overall, with no foreign odours; |
| --- | --- |

—

Aroma: intense but delicate overall, with no foreign odours;

| — | Taste: sweet, intense, with a slightly bitter aftertaste; Asparagus aroma: medium to strong. |
| --- | --- |

—

Taste: sweet, intense, with a slightly bitter aftertaste; Asparagus aroma: medium to strong.

| — | Texture: from the tip to the centre it is fleshy, juicy and tender; the remaining part down to the base is fibrous. |
| --- | --- |

—

Texture: from the tip to the centre it is fleshy, juicy and tender; the remaining part down to the base is fibrous.

New wording:‘Shoots that meet the organoleptic and trading requirements laid down in the product specification other than those concerning size and length, and which therefore do not comply with the UNECE classification referred to in the specification, may be used for processing.’

Reason:

The classification of shoots is amended to bring it into line with UNECE rules. Also, a new characteristic has been added, concerning the texture of the shoot, which is already mentioned in the section on the link.

Producers are facing new constraints as markets and seasons become more variable, leading them to reflect on a better classification of the product based on United Nations Economic Commission for Europe (UNECE) rules. This will also make it easier to market the product. Moreover, producers will be better able to meet the requirements of the market as recent experience shows that large retailers tend to prefer products with a clear classification. The sector faces considerable variability and uncertainty due to the short growing season and climatic factors that influence the product’s characteristics. This can be mitigated by increasing the product range. The variations in size accepted for each category are therefore extended, while the margin of tolerance for the Extra category is reduced from 10 % in the current specification to 5 %. By reducing variations within the bundle, a product of more uniform quality can be obtained that will be better valued by the market. Furthermore, compliance with UNECE rules also means that visual quality standards must be met that will improve the presentation of asparagus sold for fresh consumption. Operators will be required to ensure, by way of self-monitoring, that UNECE rules are complied with, including as regards visual and sensory requirements. This will ensure that a high standard is maintained for ‘Asparago di Cantello’.

The Class II category has been added to be able to meet the needs of consumers who prefer asparagus of a slightly smaller size, more suitable for certain dishes and available at a lower price, while continuing to use the registered name guaranteeing the origin of the product.

A specific requirement concerning the texture of the shoot, which was already included in the section on the link, has also been added in the description of the product.

The characteristics of the product intended for processing have been added because provision has been made for processing asparagus which does not meet the size or shape requirements and therefore cannot comply with the UNECE classification, despite having been produced and grown in accordance with the parameters set out in the specification. However, vegetables which are not healthy and do not comply with the product specification will not be processed.

Traditionally, asparagus that could not be consumed fresh would be canned, in the form of cream or sauce, or dried to be used later in various food preparations or recipes, at the farm where it was grown. This tradition should be preserved, allowing producers to market their entire, valuable asparagus crop under the PGI name, avoid waste and benefit from the value added of processing.

The following amendments concern Article 5 of the product specification ONLY, and relate to the method of production. Specifically, points 5.1, 5.2, 5.4 and 5.7 of the specification have been amended. These amendments do not affect the single document.

Article 5 Method of obtaining the product

5.1.   Production system

The crop must be grown in sandy loam soils with a pH ranging from 5,3 to 7,5.

New wording:

5.1.   Production system

The crop must be grown in soils with a pH ranging from 5,3 to 7,5.

(Deleted: sandy loam)

Reason:

The soils in the area of origin where the asparagus is grown, in the municipality of Cantello, have undergone physical and chemical analysis over time, the results of which show that all land in this area is suited to growing asparagus with the characteristics and qualities required by the product specification. The entire area has alluvial, loose and permeable soils that have traditionally been used to grow asparagus crops, as evidenced by the technical and historical file submitted at the time of registration. The soils do not need to be of the sandy loamy type to obtain asparagus with the characteristics laid down in the specification. This restriction should therefore be removed, allowing certified produce to be obtained from all the areas within the municipality of Cantello where the crop is grown. Results are available of the chemical and physical analyses of the soils carried out by the growers over the years.

The amendment affects neither the product’s characteristics, which remain unchanged, nor the reputation of the name that forms the main link between the product and the geographical area. In order to encourage the use of the PGI by small holdings located in the geographical area, and to be able to carry out crop rotation as provided for in the specification, it is important to allow all available areas to be cultivated without compromising the essential quality of the product or its link with the area.

5.2.   Cultivation techniques

Planting distance and depth The spacing between rows is 2-2,40 metres, and the seeds must be planted in furrows 20-30 cm deep.

The planting density must be between 20 000 and 25 000 plants per hectare.

New wording:

5.2.   Cultivation techniques

Planting distance and depth The spacing between rows is 2-2,80 metres, and the seeds must be planted in furrows 20-30 cm deep.

The planting density must not exceed 25 000 plants per hectare.

(Deleted: minimum planting density of 20 000 plants/ha)

Reason:

The spacing between rows should be increased. This would allow holdings that have access to machinery that can handle a greater spacing between rows to also produce asparagus under the PGI. The most mechanised holdings are often run by young farmers who would benefit from entering the certified production chain. This does not affect the other production and quality parameters laid down for ‘Asparago di Cantello’, and the maximum number of plants per hectare remains unchanged.

Linked to this amendment, the minimum planting density should be removed as it does not have any impact on quality, while the maximum number of plants per hectare remains unchanged to ensure that the quality of the product is maintained.

5.4.   Fertilisers

In the following years, fertiliser may be applied from July to August, after the harvest, on the basis of average crop uptake values.

At the end of winter organic fertiliser may be applied for maintenance.

New wording:

5.4.   Fertilisers

In the following years, fertiliser may be applied from June to November, after the harvest, on the basis of average crop uptake values.

(Deleted: At the end of winter organic fertiliser may be applied for maintenance.)

Reason:

This is a mistake that needs to be corrected, as spreading organic fertiliser around the time the asparagus is harvested raises issues both of a practical nature and in terms of hygiene and health, meaning it is not being implemented.

5.7.   Harvest

The maximum annual yield of asparagus in full production is 10 tonnes/ha.

The lifetime of the plantation must not exceed 12 years.

New wording:

5.7.   Harvest

The maximum annual yield of asparagus in full production is 10 tonnes/ha, after husking in the field.

(Deleted: The lifetime of the plantation must not exceed 12 years.)

Reason:

Including harvesting waste and harvested shoots that do not meet the PGI requirements in the PGI production makes little sense, and transporting all this to the processing facilities as if it were entirely made up of asparagus meeting the PGI requirements risks becoming only a restriction and a constraint on the safeguarding of product quality.

Moreover, the reference to the age of the plantation should be removed as this depends on the productivity of the plants, the fertility of the land, the hybrid used and the farming intensity and associated yield. The lifetime of the plantation should not be determined by the specification but rather be left up to the farmer, who is best placed to assess the economic benefit of maintaining cultivation. While some plantations may have a shorter lifetime, others benefit from particularly favourable soil and microclimatic conditions that allow their life cycle to be extended without this affecting the quality of the end product, which is in any case defined by the product specification and checked accordingly.

5.8.   Processing

The asparagus is packed in the demarcated geographical area to ensure that its characteristics are preserved. As the asparagus must be sold very fresh, i.e. soon after harvesting, it is immediately washed and packed for sale to preserve its specific qualities.

After harvesting, the asparagus is cleaned and packaged, and may be sold immediately or kept at 4 °C for a short time (not exceeding 48 hours).

New wording: (Point 5.8 of the single document and point 3.5 of the product specification have been amended.)

5.8.   Processing

The asparagus is packed in the demarcated geographical area to ensure that its characteristics are preserved. As the asparagus must be sold very fresh, i.e. soon after harvesting, it is immediately washed and packed for sale to preserve its specific qualities.

After harvesting, the asparagus may be cleaned, packaged and sold immediately, or may be kept at 4 °C for not longer than 96 hours.

(Deleted: ‘not exceeding 48 hours’).

Reason:

PGI recognition for ‘Asparago di Cantello’, which already enjoyed a remarkable reputation locally, led to increased interest from purchasers, especially large retailers. The time of delivery and turnover is determined not only by the producer, but also by the needs of the supermarkets that display and sell the products to the end consumer. Due to the requirements (of delivery, transport and storage) of the large retail chains, which are increasingly keen to promote niche products such as this high-quality asparagus, the product now tends to be kept in cold store slightly longer than before, and the indication that the asparagus must not be stored for more than 48 hours should therefore be deleted. The concept of ‘a short time’ should be kept, however, as this is necessary to underline the paramount importance of maintaining the product’s characteristic freshness as required by the specification.

Article 6 Link with the geographical area

For the amendments made, which consist of editing changes and the insertion of new paragraphs, the new or amended parts are shown below without specifying the reasons.

Point 5 of the single document and point 6 of the product specification have been amended.

Article 6 Link with the geographical area

The requested amendment consists partly of editorial changes where paragraphs have been moved to make the text more coherent and easy to read, and partly of the insertion of new paragraphs to demonstrate that the link with the geographical area is maintained with these changes. Specifically, after the paragraph starting with ‘The Cantello soil’ and ending with ‘insulating effect on the soil’, the following changes have been made:

| 1) | The following paragraph has been inserted: ‘The area is thus characterised by abundant thermal and water resources, with limitations that in no way appear to affect asparagus cultivation, and its soils are particularly well suited for this crop. These soil and climate conditions have allowed asparagus growing to become widespread and well established in Cantello.’
  Reason: This refers to the amendment of Article 5.1 of the product specification regarding the link. The wording in question has been inserted to substantiate the fact that it is not only sandy-loamy soils but the loose texture of the soils in general that make the geographical area of the PGI particularly suited for growing white asparagus. The entire area has alluvial, loose and permeable soils that have traditionally been used to grow asparagus crops, as evidenced by the technical and historical file submitted at the time of registration. The soils do not need to be of the sandy-loamy type to obtain asparagus with the characteristics laid down in the specification. |
| --- | --- |

1)

The following paragraph has been inserted: ‘The area is thus characterised by abundant thermal and water resources, with limitations that in no way appear to affect asparagus cultivation, and its soils are particularly well suited for this crop. These soil and climate conditions have allowed asparagus growing to become widespread and well established in Cantello.’

Reason: This refers to the amendment of Article 5.1 of the product specification regarding the link. The wording in question has been inserted to substantiate the fact that it is not only sandy-loamy soils but the loose texture of the soils in general that make the geographical area of the PGI particularly suited for growing white asparagus. The entire area has alluvial, loose and permeable soils that have traditionally been used to grow asparagus crops, as evidenced by the technical and historical file submitted at the time of registration. The soils do not need to be of the sandy-loamy type to obtain asparagus with the characteristics laid down in the specification.

| 2) | After the paragraph starting with ‘The long tradition’ and ending with ‘the Mecca of asparagus’, a paragraph has been inserted and entirely reworded in support of the reputation of the registered name.
  The link between the geographical area and “Asparago di Cantello” PGI is based, above all, on the reputation of the PGI name, which identifies a product which, over the centuries, has thrived on and benefited from the suitability of the area’s climate and soils for asparagus growing, and on the consolidation of a production tradition that lives on until this day.
  Reason:
  The requested changes do not weaken the link with the geographical area, which is based, among other things, on the reputation of a name denoting a traditional product that has been able to maintain its quality characteristics while respecting tradition and sustaining producers. Its recognition as a PGI provides better guarantees not only to local consumers, but also to those who have discovered the product thanks to large retailers’ interest in small producers and products with a short supply chain. |
| --- | --- |

2)

After the paragraph starting with ‘The long tradition’ and ending with ‘the Mecca of asparagus’, a paragraph has been inserted and entirely reworded in support of the reputation of the registered name.

The link between the geographical area and “Asparago di Cantello” PGI is based, above all, on the reputation of the PGI name, which identifies a product which, over the centuries, has thrived on and benefited from the suitability of the area’s climate and soils for asparagus growing, and on the consolidation of a production tradition that lives on until this day.

Reason:

| 3) | The following paragraph has been amended: “Only asparagus belonging to the Precoce d’Argenteuil variety were accepted at the fair. The 31 May 1939 edition of Cronaca Prealpina, a local newspaper, published the list of the best asparagus producers. The fair has was held for the 74th time in 2014. Each year, the beginning of May is marked by this event, which draws the interest of many fans.”
  New wording:
  Only asparagus belonging to the Precoce d’Argenteuil variety were accepted at the fair. The 31 May 1939 edition of Cronaca Prealpina, a local newspaper, published the list of the best asparagus producers, and each year the beginning of May is marked by this event, which draws the interest of many fans.’
  The sentence ‘The fair has was held for the 74th time in 2014’ has been deleted.
  Reason: The fair is a recurring event that has been held every year since 1939. It makes little sense therefore to indicate a specific year as, with each new event, the relevant year will change. |
| --- | --- |

3)

The following paragraph has been amended: “Only asparagus belonging to the Precoce d’Argenteuil variety were accepted at the fair. The 31 May 1939 edition of Cronaca Prealpina, a local newspaper, published the list of the best asparagus producers. The fair has was held for the 74th time in 2014. Each year, the beginning of May is marked by this event, which draws the interest of many fans.”

New wording:

Only asparagus belonging to the Precoce d’Argenteuil variety were accepted at the fair. The 31 May 1939 edition of Cronaca Prealpina, a local newspaper, published the list of the best asparagus producers, and each year the beginning of May is marked by this event, which draws the interest of many fans.’

The sentence ‘The fair has was held for the 74th time in 2014’ has been deleted.

Reason: The fair is a recurring event that has been held every year since 1939. It makes little sense therefore to indicate a specific year as, with each new event, the relevant year will change.

| 4) | The following paragraph has been reworded and moved to make the text easier to read and more consistent; it is a mere editorial change:
  ‘The fine-tuning of specific cultivation techniques such as forming the soil into beds in the spring, which ensures the blanching of the shoots, and harvesting, which is always done by hand, makes it possible to obtain asparagus shoots that are entirely white or with slightly pinkish tips, up to 22 cm long and completely edible. “Asparago di Cantello” maintains its integrity when cooked. The colour may vary from its uncooked state. In particular, the tip may take on a slight green tinge. The product is somewhat sweet to the taste and has a characteristic, delicate note of bitterness: the typical, unmistakable flavour of “Asparago di Cantello”. The texture of the spear from the tip to the centre is fleshy, juicy and tender; the remaining part down to the base is fibrous.’ |
| --- | --- |

4)

The following paragraph has been reworded and moved to make the text easier to read and more consistent; it is a mere editorial change:

‘The fine-tuning of specific cultivation techniques such as forming the soil into beds in the spring, which ensures the blanching of the shoots, and harvesting, which is always done by hand, makes it possible to obtain asparagus shoots that are entirely white or with slightly pinkish tips, up to 22 cm long and completely edible. “Asparago di Cantello” maintains its integrity when cooked. The colour may vary from its uncooked state. In particular, the tip may take on a slight green tinge. The product is somewhat sweet to the taste and has a characteristic, delicate note of bitterness: the typical, unmistakable flavour of “Asparago di Cantello”. The texture of the spear from the tip to the centre is fleshy, juicy and tender; the remaining part down to the base is fibrous.’

| 5) | The following paragraph has been reinserted:
  Along with tradition, there have been constant improvements in the production process as growing techniques have developed and improved cultivars, derived from those traditionally used, have become available. When planting new asparagus plots, the growers will choose the cultivars which, in their experience, are best adapted to the soil and climate conditions and best suited to bringing out the characteristics that distinguish ‘Asparago di Cantello’.
  The processing of asparagus (into sauces and purees, dried, canned, etc.), from shoots that do not comply with the specification in terms of classes, size and length, also has a long tradition. Such processing has always allowed farmers to avoid waste and to keep the asparagus for longer, thus making the most out of a product that is, in any case, of top quality.
  Reason: This paragraph has been inserted as a result of the amendment of Articles 2.1 and 2.2 of the specification and of point 3.2 of the single document introducing new cultivars, new asparagus classes and the ‘product intended for processing’ category to confirm the link between traditional processing in family businesses and the traditional production process used for ‘Asparago di Cantello’. It is in fact a tradition for asparagus that is not sold fresh to be canned so as to make good use of a valuable product and to avoid waste. |
| --- | --- |

5)

The following paragraph has been reinserted:

Along with tradition, there have been constant improvements in the production process as growing techniques have developed and improved cultivars, derived from those traditionally used, have become available. When planting new asparagus plots, the growers will choose the cultivars which, in their experience, are best adapted to the soil and climate conditions and best suited to bringing out the characteristics that distinguish ‘Asparago di Cantello’.

The processing of asparagus (into sauces and purees, dried, canned, etc.), from shoots that do not comply with the specification in terms of classes, size and length, also has a long tradition. Such processing has always allowed farmers to avoid waste and to keep the asparagus for longer, thus making the most out of a product that is, in any case, of top quality.

Reason: This paragraph has been inserted as a result of the amendment of Articles 2.1 and 2.2 of the specification and of point 3.2 of the single document introducing new cultivars, new asparagus classes and the ‘product intended for processing’ category to confirm the link between traditional processing in family businesses and the traditional production process used for ‘Asparago di Cantello’. It is in fact a tradition for asparagus that is not sold fresh to be canned so as to make good use of a valuable product and to avoid waste.

Article 7 Checks

The inspection body is CSQA Certificazioni Srl – Via S. Gaetano, 74, 36016 Thiene (VI) Italy – Tel. +39/0445313011, Fax: +39/0445313070, email: csqa@csqa.it.

New wording:

Article 7 Checks
  (Article 7 of the product specification has been amended)

The inspection body is Check Fruit srl – via Boldrini 24, 40121 Bologna, Italy – Tel: +39/0516494836, email: info@checkfruit.it, PEC: checkfruit@pec.it.

Reason:

At an extraordinary meeting of 19 April 2020, Check Fruit was designated as the new inspection body.

Article 8 Labelling

The asparagus is usually packed in bundles of at least 0.5 kg or loose in boxes in line with tradition, but packaging permitted by current legislation may also be used. Asparagus intended for processing which therefore may not be sold to the end consumer may also be delivered ‘loose’, in packages or containers that comply with the legislation in force and feature, on at least one of the sides, in clear and legible print, the wording ‘Asparago di Cantello IGP destinato alla trasformazione’ (‘Asparago di Cantello PGI intended for processing’). The packs must have a wrapper, which must show, in the same field of view, the name ‘Asparago di Cantello I.G.P.’ (‘Asparago di Cantello PGI’), the EU PGI symbol and the producer’s name, business name and address.

New wording:

Article 8 Packaging and labelling

Packaging (Article 8 of the specification and point 3.5 of the single document have been amended)

Asparagus intended for the end consumer is packed in bundles of at least 0,5 kg; it may also be packed in boxes using packaging permitted by current legislation.

Asparagus intended for processing may also be delivered loose, in packages or containers complying with current legislation.

Labelling (Article 8 of the specification and point 3.6 of the single document have been amended)

The packs must have a wrapper, which must show, in the same field of view, the name ‘Asparago di Cantello I.G.P.’ (‘Asparago di Cantello PGI’), the EU PGI symbol and the producer’s name, business name and address.

Packs of asparagus intended for processing must show, on at least one of the sides, the wording ‘Asparago di Cantello IGP destinato alla trasformazione’ (‘Asparago di Cantello PGI intended for processing’) in clear and legible print.

Reason:

With the introduction of processing operations there is a need for greater clarity, and the rules on packaging should therefore be set out separately from those on labelling, distinguishing between the fresh product intended for the end consumer and the product intended for processing.

Given the interest shown by large retailers in ‘Asparago di Cantello’ to be consumed fresh, a larger choice of packaging should be allowed, adapted to the needs of individual customers and with a view to preserving the product’s freshness and making it more accessible to the end consumer.

The introduction of rules on the labelling and traceability of asparagus intended for processing makes the origin of packaged products containing ‘Asparago di Cantello’ PGI more transparent: asparagus intended for processing must comply with the characteristics set out in the specification and the packaging must be recognisable and traceable.

The graphic image of the logo has been inserted together with the instructions of use.

SINGLE DOCUMENT

‘Asparago di Cantello’

EU No: PGI-IT-01267-AM01 – 23.3.2021

PDO ( ) PGI (X)

1.   Name

‘Asparago di Cantello’

2.   Member State or Third Country

Italy

3.   Description of the agricultural product or foodstuff

3.1.   Type of product

Class 1.6. Fruit, vegetables and cereals, fresh or processed

3.2.   Description of product to which the name in (1) applies

The cultivars used for the production of ‘Asparago di Cantello’ are Precoce d’Argenteuil and its derived hybrids and other asparagus cultivars (Grolim, Zeno, Cumulus, Vitalim, Giove, Vittorio, Eros, Franco, Fruhlim, Magnus, Herkolim, Terralim) that are suitable for the production of white asparagus with the characteristics set out in the product specification.

Morphological characteristics

‘Asparago di Cantello’ shoots must be entirely white, or have slightly pinkish tips. The shoots must be:

| — | whole |
| --- | --- |

—

whole

| — | fresh in appearance |
| --- | --- |

—

fresh in appearance

| — | free of deformities and bruises. |
| --- | --- |

—

free of deformities and bruises.

‘Asparago di Cantello’, which must not exceed 22 cm in length, is classified into the following three UNECE quality classes:

| — | Extra: (minimum diameter: 12 mm and above) |
| --- | --- |

—

Extra: (minimum diameter: 12 mm and above)

| — | Class I: (minimum diameter: 10 mm) |
| --- | --- |

—

Class I: (minimum diameter: 10 mm)

| — | Class II: (minimum diameter: 8 mm) |
| --- | --- |

—

Class II: (minimum diameter: 8 mm)

In each individual pack within the same class there is a margin of tolerance, in terms of weight, of 10 % for Class I and Class II and 5 % for Extra for shoots not meeting the required size.

Organoleptic and chemical-physical characteristics

The organoleptic analysis produced the following results:

| — | Aroma: intense but delicate overall, with no foreign odours; |
| --- | --- |

—

Aroma: intense but delicate overall, with no foreign odours;

| — | Taste: sweet, intense, with a slightly bitter aftertaste; Asparagus aroma: medium to strong. |
| --- | --- |

—

Taste: sweet, intense, with a slightly bitter aftertaste; Asparagus aroma: medium to strong.

| — | Texture: from the tip to the centre it is fleshy, juicy and tender; the remaining part down to the base is fibrous.
  The chemical-physical analysis produced the following results:







  Energy value | 21 -23 | kcal/100 g |
| --- | --- | --- | --- |
| Fat | 0,11 -0,14 | g/100 g |
| Carbohydrates | 3,01 -3,55 | g/100 g |
| Ash | 0,42 -0,46 | g/100 g |
| Protein (N x 6,25) | 1,51 -1,54 | g/100 g |
| Dietary fibre | 0,50 -0,96 | g/100 g |
| Moisture | 93,40 -94,12 | g/100 g |

—

Texture: from the tip to the centre it is fleshy, juicy and tender; the remaining part down to the base is fibrous.

The chemical-physical analysis produced the following results:

Energy value

21 -23

kcal/100 g

Fat

0,11 -0,14

g/100 g

Carbohydrates

3,01 -3,55

g/100 g

Ash

0,42 -0,46

g/100 g

Protein (N x 6,25)

1,51 -1,54

g/100 g

Dietary fibre

0,50 -0,96

g/100 g

Moisture

93,40 -94,12

g/100 g

Shoots that meet the organoleptic and trading requirements laid down in the specification other than those concerning size and length, and which therefore do not comply with the UNECE classification referred to in the specification, may be used for processing.

3.3.   Feed (for products of animal origin only) and raw materials (for processed products only)

—

3.4.   Specific steps in production that must take place in the identified geographical area

All cultivation, harvesting, packaging and pre-packaging storage must take place in the identified geographical area.

3.5.   Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to

The asparagus is packed in the demarcated geographical area to ensure that its characteristics are preserved. As the asparagus must be sold fresh, i.e. soon after harvesting, it is immediately washed and packed for sale to preserve its special organoleptic qualities. It may be sold immediately or kept at 4 °C for a short time (not exceeding 96 hours).

Asparagus intended for the end consumer is packed in bundles of at least 0,5 kg; it may also be packed in boxes using packaging permitted by current legislation.

Asparagus intended for processing may also be delivered loose, in packages or containers complying with current legislation.

3.6.   Specific rules concerning labelling of the product the registered name refers to

The packs must have a wrapper, which must show, in the same field of view, the name ‘Asparago di Cantello I.G.P.’ (‘Asparago di Cantello PGI’), the EU PGI symbol and the producer’s name, business name and address.

Packs of asparagus intended for processing only need to show, on at least one of the sides, the wording ‘Asparago di Cantello PGI intended for processing’ in clear and legible print.

On bundles and on packaging intended for the final consumer, indications and/or images referring to company names, trade names or logos of consortia or individual companies may be used together with the protected geographical indication.

The label must show, inseparably linked to the geographical indication, the logo of ‘Asparago di Cantello’ PGI, i.e. the distinctive symbol.

The Asparago di Cantello logo shall consist of the following two components.

Two white asparagus spears with violet tips and mottling, arranged in a V shape, with the left-hand asparagus spear placed on top of the other. Above the point at which the two asparagus spears meet, the words ‘ASPARAGO DI CANTELLO IGP’ (‘Asparago di Cantello PGI’) shall be displayed in white letters on a red background.

Behind the two asparagus spears, enclosed in an arc, there shall be an image representing the Madonna in Campagna church in Cantello, with a mountain backdrop showing a blue sky and the sun. The edge of the arc is in the colours of the rainbow.

Image 2

4.   Concise definition of the geographical area

The cultivation of ‘Asparago di Cantello’ must take place in the municipality of Cantello, Varese province.

5.   Link with the geographical area

The Cantello soil, of fluvio-glacial origin, with its particularly loose structure, high permeability and fast drainage, is rich in organic substances, has a pH varying between 5.3 and 7.5, and is highly suited to the cultivation of asparagus. The local climate is connected with the European macroclimate and the Insubric mesoclimate, which is a transition mesoclimate between that of the Po valley and that of the Alps. The distribution of precipitation is characterised by low rainfall in winter and the highest rainfall from late spring to autumn. The fact that rainfall is at its heaviest when the need for transpiration and evaporation is at its highest means that summer water stress for crops is a rare occurrence. Precipitation in the form of snow provides a highly efficient source of water supply as well as having a positive insulating effect on the soil.

The area is thus characterised by abundant thermal and water resources, with limitations that in no way appear to affect asparagus cultivation, and its soils are particularly well suited for this crop. These soil and climate conditions have allowed asparagus growing to become widespread and well established in Cantello.

The long tradition of cultivation has led to the name of Cantello being firmly associated in people’s minds with asparagus. The consolidation of this tradition has led to Cantello being defined as the ‘Mecca of asparagus’.

The link between the geographical area and “Asparago di Cantello” PGI is based, above all, on the reputation of the PGI name, which identifies a product which, over the centuries, has thrived on and benefited from the suitability of area’s climate and soils for asparagus growing, and on the consolidation of a manufacturing tradition that lives on until this day.

News stories dating back to 1831 on the cultivation of asparagus in Cantello have been found in the local archives. Historical documents show that asparagus was given to the church and then auctioned by the parish priest to help fund the church's spending. Over the years, the role of asparagus has grown to become one of fundamental importance for the town. Cantello’s farmers sold the asparagus locally or in neighbouring Switzerland.

An illustrious Cantello lawyer, Cesare Baj, used part of the income from his property to fund a prize for the best producers, the aim being to encourage farmers to improve the production of asparagus year after year.

In 1939, on the occasion of the prize giving, the Cantello Asparagus Fair was set up, which has become a traditional event that attracts both local residents and those of other towns in the province. Only asparagus belonging to the Precoce d’Argenteuil variety were accepted at the fair. The 31 May 1939 edition of Cronaca Prealpina, a local newspaper, published the list of the best asparagus producers, and each year the beginning of May is marked by this event, which draws the interest of many fans.’

The fine-tuning of specific cultivation techniques such as forming the soil into beds in the spring, which ensures the blanching of the shoots, and harvesting, which is always done by hand, makes it possible to obtain asparagus shoots that are entirely white or with slightly pinkish tips, up to 22 cm long and completely edible. ‘Asparago di Cantello’ maintains its integrity when cooked.

The colour may vary from its uncooked state. In particular, the tip may take on a slight green tinge. The product is somewhat sweet to the taste and has a characteristic, delicate note of bitterness: the typical, unmistakable flavour of ‘Asparago di Cantello’.

The texture of the spear from the tip to the centre is fleshy, juicy and tender; the remaining part down to the base is fibrous.

Along with tradition, there have been constant improvements in the production process as growing techniques have developed and improved cultivars, derived from those traditionally used, have become available. When planting new asparagus plots, the growers will choose the cultivars which, in their experience, are best adapted to the soil and climate conditions and best suited to bringing out the characteristics that distinguish ‘Asparago di Cantello’.

The processing of asparagus (into sauces and purees, dried, canned, etc.), from shoots that do not comply with the specification in terms of classes, size and length, also has a long tradition. Such processing has always allowed farmers to avoid waste and to keep the asparagus for longer, thus making the most out of a product that is, in any case, of top quality.

The reputation of ‘Asparago di Cantello’ has also reached today’s communication channels. There are many websites devoted to this product, and cooking programmes featuring ‘Asparago di Cantello’ presented by famous chefs are even frequently shared on YouTube. The taste of ‘Asparago di Cantello’ has been appreciated by many gourmets over the years and the local restaurants have specialised in asparagus-based dishes.

In restaurants, shops and supermarkets, ‘Asparago di Cantello’ is presented under this name.

The wide-ranging economic, cultural and social interest in this product, strengthened by its PGI status, has made it possible to develop and improve cultivation techniques, sales and marketing strategies and, in keeping with tradition, to maintain production that provides a small area with prestige as well as income whilst fostering local cooperation and protection of the rural environment.

Reference to publication of the product specification

The full text of the product specification is available on the following website: http://www.politicheagricole.it/flex/cm/pages/ServeBLOB.php/L/IT/IDPagina/3335

or alternatively:

by going directly to the home page of the Ministry of Agricultural, Food and Forestry Policy (www.politicheagricole.it) and clicking on ‘Qualità’ (at the top right of the screen), then on ‘Prodotti DOP IGP STG’ (on the left-hand side of the screen) and finally on ‘Disciplinari di Produzione all’esame dell’UE’.

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(1)  OJ L 343, 14.12.2012, p. 1.

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| 8.5.2023 | EN | Official Journal of the European Union | C 163/33 |
| --- | --- | --- | --- |

8.5.2023

EN

Official Journal of the European Union

C 163/33

---

Publication of an approved standard amendment to the product specification of a protected designation of origin or protected geographical indication in the agricultural products and foodstuffs sector, as referred to in Article 6b(2) and (3) of Commission Delegated Regulation (EU) No 664/2014

(2023/C 163/13)

This communication is published in accordance with Article 6b(5) of Commission Delegated Regulation (EU) No 664/2014 (1).

Communicating the approval of a standard amendment to the product specification of a protected designation of origin or protected geographical indication originating in a Member State

(Regulation (EU) No 1151/2012)

‘Chosco de Tineo’

EU No: PGI-ES-0696-AM01 – 9.2.2023

PGI (X) PDO ( )

1.   Name of product

‘Chosco de Tineo’

2.   Member State to which the geographical area belongs

Spain

3.   National authority or applicant group communicating the standard amendment

Consejo Regulador de la Indicación Geográfica Protegida Chosco de Tineo (Regulatory Board for the protected geographical indication ‘Chosco de Tineo’)

Address: Pol. Industrial de La Curiscada, C.P.E. de Tineo, Santa Eulalia de Tineo, Asturias, Spain

Tel. +34 985801976

Email: info@igpchoscodetineo.com

Internet: https://igpchoscodetineo.com/

4.   Description of the approved amendment(s)

4.1.   Section E – Method of production

In Section E, ‘Method of production’, the minimum smoking period required to obtain the product’s characteristic aroma has been reduced from 8 days (in the previous product specification) to 5 days.

This amendment also affects the single document.

Reasons:

The smoking of meat products is a traditional process carried out to ensure that the products keep as well as possible in areas of high humidity. The aim is to reduce the moisture content of products so as to improve their stability, thereby extending the products’ shelf life and improving food safety. Traditional smoking also gives the product specific organoleptic characteristics, typical of products smoked using artisanal methods.

The smoking process can, however, cause contaminants such as polycyclic aromatic hydrocarbons (PAHs) to be deposited in food. The PAHs produced when wood is burned are of major relevance to the food safety of the product, as EU regulations impose limits on the concentration of certain PAHs in smoked meat products (benzo[a]pyrene, benz[a]anthracene, benzo[b]fluoranthene and chrysene) because they are considered to be potentially carcinogenic contaminants.

It has therefore been recommended to minimise the smoking time of agri-food products so as to ensure that the concentration of those contaminants does not exceed the limits in force and is as low as possible in the final product.

The minimum smoking period laid down in the product specification for the ‘Chosco de Tineo’ PGI is currently 8 days. The purpose of this smoking process is to give the choscos their smoky characteristics.

It is therefore requested that the product specification for the ‘Chosco de Tineo’ PGI be amended to reflect the fact that the minimum smoking period has been reduced to 5 days, which is enough time to give the final product the requisite physico-chemical and organoleptic characteristics.

This is considered to be a standard amendment because it does not affect any key elements. Reducing the minimum number of days for which the product is smoked does not affect its characteristics. This amendment should not be classified under any of the four points laid down in Article 53(2) of Regulation (EU) No 1151/2012 for an amendment to be regarded as a Union amendment.

4.2.   Section D – Proof that the product originated in the area

Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs requires compliance with product specifications to be verified by the competent authority or by control bodies operating as a product certification body.

Article 36 of Act of Asturias No 2/2019 of 1 March 2019 on food quality, quality schemes and direct sale of food products allows control activities to be delegated to the control body, which is not the regulatory board.

For this reason, the term ‘regulatory board’ has been replaced by ‘control body’ in the points in the product specification relating to delegated control tasks. It is also proposed to delete the ‘Breakdown of checks’ table, in which the ‘control body of the regulatory board’ is listed as the body responsible.

In addition, the statement that labels or numbered certification labels ‘must be provided’ by the control body has been deleted so that the labels do not have to be supplied exclusively by that body, although the control body is in any case responsible for authorising the labels.

It is proposed that the frequency with which operators must submit production declarations be reduced to ‘at least once a year’, this being considered sufficient to verify the quantity of certified product.

This is considered to be a standard amendment because it does not affect any key elements. This amendment should not be classified under any of the four points laid down in Article 53(2) of Regulation (EU) No 1151/2012 for an amendment to be regarded as a Union amendment.

4.3.   Section H – Labelling

The statement that labels or numbered certification labels must be supplied by the regulatory board has been deleted from this section too, as in Section D.

The term ‘regulatory board’ has been replaced by ‘control body’ as the body responsible for authorising labels and/or certification labels before they are used by operators.

The words ‘NB: the last four paragraphs are not included in the single document, although they did not appear in the first single document submitted either.’ have been deleted.

This is considered to be a standard amendment because it does not affect any key elements. This amendment should not be classified under any of the four points laid down in Article 53(2) of Regulation (EU) No 1151/2012 for an amendment to be regarded as a Union amendment.

4.4.   Section D – Proof that the product originated in the area

5.2.1.   References to checks by operators

As regards the system for internal verification of compliance with the product specification by operators, it is proposed that the word ‘checks’ be changed to ‘self-checks’ in order to avoid any misunderstanding.

This is considered to be a standard amendment because it is a drafting amendment not affecting any of the four points laid down in Article 53(2) of Regulation (EU) No 1151/2012 for an amendment to be regarded as a Union amendment.

4.5.   Section G – Control body

It is proposed that the information contained in Section G, Control body, be deleted and replaced by the following two paragraphs, in line with the inclusion of the body with authority to verify compliance with the product specification pursuant to Regulation (EU) No 1151/2012 and Act of Asturias No 2/2019.

‘The competent authority for control is the Directorate-General from the Asturian Government whose remit includes agri-food matters.

Control may be delegated to an entity acting as a product certification body and accredited under Standard UNE-EN ISO/IEC 17065, or any standard that may replace it in the future.’

This is considered to be a standard amendment because it does not affect any key elements. This amendment should not be classified under any of the four points laid down in Article 53(2) of Regulation (EU) No 1151/2012 for an amendment to be regarded as a Union amendment.

4.6.   Section I – National requirements

Section I – National requirements

5.7.1.   Deletion of national legislative requirements

It is proposed that Section I of the product specification be deleted because some of the texts listed there have been repealed.

This is considered to be a standard amendment because it does not affect any key elements. This amendment should not be classified under any of the four points laid down in Article 53(2) of Regulation (EU) No 1151/2012 for an amendment to be regarded as a Union amendment.

https://www.asturias.es/documents/217090/555882/20221214_Pliego_de_condiciones_+sin+control+de_cambios.pdf/6a45427c-b2f6-c76f-aad9-eb1193eb0b43?t=1671009266981

SINGLE DOCUMENT

‘Chosco de Tineo’

‘Chosco de Tineo’

EU No: PGI-ES-0696-AM01 – 9.2.2023

EU No: PGI-ES-0696-AM01 – 9.2.2023

PGI (X) PDO ( )

PGI (X) PDO ( )

1.   Name(s) [of PDO or PGI]

Name(s) [of PDO or PGI]

‘Chosco de Tineo’

2.   Member State or Third Country

Member State or Third Country

Spain

3.   Description of the agricultural product or foodstuff

Description of the agricultural product or foodstuff

3.1.   Type of product [listed in Annex XI]

Type of product [listed in Annex XI]

Class 1.2. Meat products (cooked, salted, smoked, etc.)

3.2.   Description of product to which the name in (1) applies

Description of product to which the name in (1) applies

Meat product made from select cuts of pork loin and tongue, seasoned with salt, paprika and garlic, packed in pig’s intestine, which gives it its characteristic shape, smoked and cured uncooked.

It has a round, irregular shape and weighs between 500 g and 2 000 g. It has a reddish colour, a firm consistency and a characteristic appearance when cut, with the different pieces of meat used being clearly visible.

Its moisture content is a minimum of 40 %, the fat content 41 % or less of the dry matter and the protein content more than 50 % of the dry matter.

The aroma and taste are characteristic of smoked sausage, which may be more or less intense depending on the smoking time, with a juicy texture.

3.3.   Feed (for products of animal origin only) and raw materials (for processed products only)

Feed (for products of animal origin only) and raw materials (for processed products only)

The following cuts of pigmeat are used: a minimum of 80 % loin and a minimum of 15 % tongue, seasoned with salt, paprika and garlic.

3.4.   Specific steps in production that must take place in the identified geographical area

Specific steps in production that must take place in the identified geographical area

Production (selection and cutting-up of the raw material, mixing, filling, smoking and drying) takes place in the defined geographical area.

The chosco is smoked to preserve it using dry wood of local species (oak, birch, beech or chestnut), as this helps it dry out in this area of high relative humidity.

chosco

To permit verification that all the production procedures and the quality of the product covered by the PGI meet all the requirements, production undertakings must complete all the documentation and registers necessary and make them available to the regulatory board. That documentation includes:

| — | records of deliveries of raw materials, detailing the supplier, the delivery note or invoice number, the quantity, the type of product and the date of delivery. Batches must be identified; |
| --- | --- |

—

records of deliveries of raw materials, detailing the supplier, the delivery note or invoice number, the quantity, the type of product and the date of delivery. Batches must be identified;

| — | production records, detailing all stages in the production process, including the dates of production, smoking and drying, showing the raw-material batch number(s) and the production batch number; |
| --- | --- |

—

production records, detailing all stages in the production process, including the dates of production, smoking and drying, showing the raw-material batch number(s) and the production batch number;

| — | dispatch records for the finished product, showing the batch number, dispatch date, the quantity of product, the dispatch note number and the destination; |
| --- | --- |

—

dispatch records for the finished product, showing the batch number, dispatch date, the quantity of product, the dispatch note number and the destination;

| — | the batch register relates the raw material to the final product, based on the information from the production records and the dispatch records, thus ensuring traceability. |
| --- | --- |

—

the batch register relates the raw material to the final product, based on the information from the production records and the dispatch records, thus ensuring traceability.

3.5.   Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to

Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to

The chosco may be sold whole, cooked or uncooked. There are no packaging restrictions for uncooked chosco. Cooked chosco must be packed for reasons of food safety and to maintain quality, since cooking softens the pig intestine used for the casing, making it more vulnerable to external factors that might cause it to split during handling. It must therefore be packed on the producer’s premises before dispatch.

chosco

chosco

chosco

3.6.   Specific rules concerning labelling of the product the registered name refers to

Specific rules concerning labelling of the product the registered name refers to

All choscos marketed as ‘Chosco de Tineo’ PGI, irrespective of how they are presented, must bear, in addition to the commercial label, a special numbered certification label bearing the words ‘Indicación Geográfica Protegida “Chosco de Tineo”’ and the logo (standard for all producers). That label must be affixed before the product is dispatched in such a way as to render reuse impossible. The label is shown below in the three possible colour options.

choscos

Image 3

4.   Concise definition of the geographical area

Concise definition of the geographical area

The production area comprises the municipalities of Allande, Belmonte de Miranda, Cangas del Narcea, Salas, Somiedo, Tineo, Valdés and Villayón in the west of Asturias (Spain), in the north of the Iberian peninsula, bounded by the autonomous communities of Cantabria, Castile and Leon, and Galicia.

This is the production area covered by the PGI.

5.   Link with the geographical area

Link with the geographical area

5.1.   Specificity of the geographical area

Specificity of the geographical area

The short distance from the coast to the watershed is generally broken by steep slopes, orographic elements that give rise to two clearly distinct zones.

A western, inland zone comprising outcrops and passes with a southerly aspect and a southern central zone lying in the north comprising the coastal mountain ranges, running east to west, with a small coastal strip.

This configuration, with its very uneven terrain, widely contrasting physiography and many valleys and mountain ranges, culminating in the Cantabrian Cordillera, creates a climate that brings plentiful precipitation throughout the year, moderate sunshine and lots of cloud.

In addition, the area’s orography and climate have a huge influence on the way of life of the inhabitants of these villages, who have to adapt to local environmental conditions.

The long winter periods in which the villages are isolated and the possibility of exploiting natural resources in summer on the pastures of the mountain passes meant that livestock farming was one of the main means of subsistence. Pigs played a vital role and were kept in all villages, since the need for self-sufficiency determined by this environment meant that pigs could be fed on organic waste, agricultural by-products (cabbage stalks, turnips, beet, damaged apples) and forest resources (chestnuts, acorns, wild vegetation), all abundant in the area.

Pig production was therefore continued. The pigs used were of Celtic breeds, whose characteristics allowed the best use of the resources of the countryside. These have gradually been replaced by selected, more productive animals, and while these have not been able to fulfil the recycling role played by the Celtic breeds, production systems have been adapted and today their meat is used in ‘Chosco de Tineo’, although those fattened in the area are still the most prized for producing this product.

This special sausage, the product of an area where the raw material was readily available, was also the result of production methods in harmony with local conditions.

The high relative humidity due to the atmospheric conditions, together with isolation from neighbours during winter months, has led to special measures being developed to preserve the product. In this case, the method adopted to preserve and dry the sausage was smoking. Initially, gorse wood, very plentiful in the area, was used, allowing other indigenous leafy woods to be spared, although these gradually came to replace gorse as they started to become less sought after for other purposes. These woods continue to be used today and give an aroma and taste similar to that produced by gorse wood, although with slight differences.

Smoking is still carried out today using traditional methods, although the wood fire is no longer lit on the ground but in braziers or other movable apparatuses known as cocinas de ahumado [smoking stoves]. The choscos are left in the smoking rooms (ahumaderos) for a minimum of 5 days, hanging from bars attached to the roof or from frames known as carros.

cocinas de ahumado

choscos

ahumaderos

carros

Smoking is followed by the actual drying. Mention should be made of the relevance to this drying process of the vaqueiros de alzada [nomadic cowherds] living in certain of the area’s villages. They generally lived by raising cattle and moved up to the high mountains with their families and livestock (including pigs) from April to October. Among the goods they took with them on these journeys were choscos, which they used as typical food for the mountain pastures, where they were specially finished by drying at a higher altitude. When these journeys were not made, drying was carried out in an hórreo, a traditional, very well-ventilated construction. Today it is carried out on premises allowing good ventilation for a minimum of 8 days until the required moisture content is achieved.

vaqueiros de alzada

choscos

hórreo

5.2.   Specificity of the product

Specificity of the product

‘Chosco de Tineo’ is made exclusively from cuts of pork loin and tongue, seasoned, packed by hand in pig’s intestine, smoked and dried, giving it characteristics that differ from those of other types of sausage. When cut, the different pieces of meat used are clearly visible. The meat must not be minced.

5.3.   Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI)

Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI)

The characteristics of ‘Chosco de Tineo’ are due to the natural environment of the area, where pig-breeding played a particularly important role, and to a specific production method, the result, on the one hand, of a rainy climate and mountainous terrain that isolates the villages for part of the year and, on the other, of the fact that it is a special sausage made with high-quality cuts, which means that it is reserved mainly for special occasions.

Of the products made when pigs are slaughtered, chosco is one of the most deeply rooted in the defined area. Its production methods have been handed down from one generation to the next, maintaining their artisanal character, and the product enjoys an excellent reputation, attested to by the public regard in which it is held and by documentary references.

chosco

There are references in documents of the Monasteries of Obona (Tineo), Corias (Cangas del Nancea) and Belmonte, and by-laws adopted by towns and parishes reflect the importance of pig-breeding in the area. The Catastro de Ensenada [land registry] records that the area had the largest herd in Asturias in the 18th century. In 1897, in their work entitled Asturias, O. Bellmunt and F. Canella point to pig-breeding as one of the main sources of wealth, and the Gran Enciclopedia Asturiana (Gijón, 1980) and J. E. Lamuño stress the size of the famous weekly suckling-pig markets in Tineo.

Catastro de Ensenada

Asturias

Gran Enciclopedia Asturiana

As for the region’s pig-meat processors, it should be noted that today the most famous are those in Tineo, their sausages, and particularly ‘Chosco de Tineo’, being the area’s most important food product. In the second half of the 19th century, in Asturias, O. Bellmunt and F. Canella were already mentioning sausage manufacturers in the municipality of Valdés and at the beginning of the 20th century Tineo was the site of the La Asunción sausage factory.

Asturias

The origin of the word chosco is uncertain, but José Ántonio Fidalgo suggests that it comes from the Latin luscus, meaning one-eyed or almost blind. The word is from Bable, the Western Asturian language, and is peculiar to the south-west of Asturias (Tineo, Allande, Cangas del Narcea, etc.) In the Middle Ages, the name ‘Tineo’ covered the district from Cabruñana en Salas to Leitariegos in the mountains. In addition, what is now called Cangas del Narcea was known as Cangas de Tineo until the 19th century.

chosco

luscus

Bable

In 1920, in his Remembranzas de antaño y hogaño de la villa de Tineo, the chronicler Claudio Zardaín writes of the chosco that was enjoyed at the local festival of San Roque.

Remembranzas de antaño y hogaño de la villa de Tineo

chosco

In 1929 Dionisio Pérez (under the pseudonym ‘Post-Thebussem’), in his Guía del buen comer español, alludes to chosco as a sausage and asserts that it is a characteristic dish in Tineo on San Roque’s Day.

Guía del buen comer español

chosco

In his Guía de Productos de la Tierra (Madrid, 1998), Lucas Pallarés writes that choscu is a noble product that originated with the vaqueiros de alzada.

Guía de Productos de la Tierra

choscu

vaqueiros de alzada

The Inventario Español de Productos Tradicionales, published by the Ministry of Agriculture, Fisheries and Food as part of the ‘Euroterroirs’ project funded by the European Union, also associates the product with the Tineo district, from which it gets its name ‘Chosco de Tineo’.

Inventario Español de Productos Tradicionales

Analyses are regularly carried out to ensure that the physical and organoleptic properties to which it owes its reputation are being maintained. The criteria used for characterising the product and the analysis results obtained are given in point 3.2 of this document. These must not vary over time.

Every year the regional press reports on the festivals and culinary days organised around ‘Chosco de Tineo’.

Reference to publication of the product specification

Reference to publication of the product specification

(the second subparagraph of Article 6(1) of the Regulation)

https://www.asturias.es/documents/217090/555882/20221214_Pliego_de_condiciones_+sin+control+d e_cambios.pdf/6a45427c-b2f6-c76f-aad9-eb1193eb0b43?t=1671009266981

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(1)  OJ L 179, 19.6.2014, p. 17.

1

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