# Official Journal C 358/2013

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2013.358.eng |
| --- | --- |
| Official Journal
  of the European Union | C 358 |
| | |
| English edition | Information and Notices | Volume 567 December 2013 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2013.358.eng

Official Journal

of the European Union

C 358

English edition

Information and Notices

Volume 567 December 2013

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2013/C 358/01 | Non-opposition to a notified concentration (Case COMP/M.7038 — Nippon Express/Panasonic Corporation/Panasonic Logistics) (
  1
  ) | 1 |
| 2013/C 358/02 | Non-opposition to a notified concentration (Case COMP/M.7043 — GDF Suez/Balfour Beatty (UK Facilities Management)) (
  1
  ) | 1 |
| 2013/C 358/03 | Communication from the Commission concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 April to 30 June 2014 under certain quotas opened by the European Union for poultrymeat products | 2 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2013/C 358/01

Non-opposition to a notified concentration (Case COMP/M.7038 — Nippon Express/Panasonic Corporation/Panasonic Logistics) (
  1
  )

1

1

2013/C 358/02

Non-opposition to a notified concentration (Case COMP/M.7043 — GDF Suez/Balfour Beatty (UK Facilities Management)) (
  1
  )

1

1

2013/C 358/03

Communication from the Commission concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 April to 30 June 2014 under certain quotas opened by the European Union for poultrymeat products

2

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | Council |
| 2013/C 358/04 | Council Decision of 2 December 2013 appointing the members and alternate members of the Advisory Committee on Safety and Health at Work for Croatia, Hungary, Portugal and the United Kingdom | 3 |
| 2013/C 358/05 | Council Decision of 2 December 2013 appointing the members and alternate members of the Governing Board of the European Foundation for the Improvement of Living and Working Conditions | 5 |
| | European Commission |
| 2013/C 358/06 | Euro exchange rates | 9 |
| | European Data Protection Supervisor |
| 2013/C 358/07 | Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposals for a regulation on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and regulation (EC) No 1223/2009 and a regulation on in vitro diagnostic medical devices | 10 |
| 2013/C 358/08 | Executive summary of the Opinion of the European Data Protection Supervisor on the Communication from the Commission on eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century | 13 |
| 2013/C 358/09 | Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposal for a Regulation amending Council Regulation (EC) No 1346/2000 on insolvency proceedings | 15 |
| 2013/C 358/10 | Executive summary of the Opinion of the European Data Protection Supervisor on the Communication from the Commission on The Digital Agenda for Europe — Driving European growth digitally | 17 |
| 2013/C 358/11 | Executive summary of the Opinion of the European Data Protection Supervisor on the Commission Proposal for a Regulation on occurrence reporting in civil aviation and repealing Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007, Commission Regulation (EC) No 1330/2007 and Article 19 of Regulation (EU) No 996/2010 | 19 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

2013/C 358/04

Council Decision of 2 December 2013 appointing the members and alternate members of the Advisory Committee on Safety and Health at Work for Croatia, Hungary, Portugal and the United Kingdom

3

2013/C 358/05

Council Decision of 2 December 2013 appointing the members and alternate members of the Governing Board of the European Foundation for the Improvement of Living and Working Conditions

5

European Commission

2013/C 358/06

Euro exchange rates

9

European Data Protection Supervisor

2013/C 358/07

Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposals for a regulation on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and regulation (EC) No 1223/2009 and a regulation on in vitro diagnostic medical devices

10

2013/C 358/08

Executive summary of the Opinion of the European Data Protection Supervisor on the Communication from the Commission on eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century

13

2013/C 358/09

Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposal for a Regulation amending Council Regulation (EC) No 1346/2000 on insolvency proceedings

15

2013/C 358/10

Executive summary of the Opinion of the European Data Protection Supervisor on the Communication from the Commission on The Digital Agenda for Europe — Driving European growth digitally

17

2013/C 358/11

Executive summary of the Opinion of the European Data Protection Supervisor on the Commission Proposal for a Regulation on occurrence reporting in civil aviation and repealing Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007, Commission Regulation (EC) No 1330/2007 and Article 19 of Regulation (EU) No 996/2010

19

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2013/C 358/12 | Prior notification of a concentration (Case COMP/M.6927 — Goldman Sachs/TPG Lundy/Barclays/Intertain) — Candidate case for simplified procedure (
  1
  ) | 22 |
| 2013/C 358/13 | Prior notification of a concentration (Case COMP/M.6817 — Allianz/Axa/Covéa/Generali/CSCA/Netproassur) — Candidate case for simplified procedure (
  1
  ) | 24 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2013/C 358/12

Prior notification of a concentration (Case COMP/M.6927 — Goldman Sachs/TPG Lundy/Barclays/Intertain) — Candidate case for simplified procedure (
  1
  )

1

22

2013/C 358/13

Prior notification of a concentration (Case COMP/M.6817 — Allianz/Axa/Covéa/Generali/CSCA/Netproassur) — Candidate case for simplified procedure (
  1
  )

1

24

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

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(1)   Text with EEA relevance

1

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

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 7.12.2013 | EN | Official Journal of the European Union | C 358/1 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/1

---

Non-opposition to a notified concentration

(Case COMP/M.7038 — Nippon Express/Panasonic Corporation/Panasonic Logistics)

(Text with EEA relevance)

2013/C 358/01

On 28 November 2013, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | in the merger section of the Competition 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 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/en/index.htm) under document number 32013M7038. EUR-Lex is the online access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32013M7038. EUR-Lex is the online access to the European law.

---

| 7.12.2013 | EN | Official Journal of the European Union | C 358/1 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/1

---

Non-opposition to a notified concentration

(Case COMP/M.7043 — GDF Suez/Balfour Beatty (UK Facilities Management))

(Text with EEA relevance)

2013/C 358/02

On 29 November 2013, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | in the merger section of the Competition 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 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/en/index.htm) under document number 32013M7043. EUR-Lex is the online access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32013M7043. EUR-Lex is the online access to the European law.

---

| 7.12.2013 | EN | Official Journal of the European Union | C 358/2 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/2

---

Communication from the Commission concerning the quantity not applied for to be added to the quantity fixed for the subperiod 1 April to 30 June 2014 under certain quotas opened by the European Union for poultrymeat products

2013/C 358/03

Commission Regulation (EC) No 616/2007 (1) opened tariff quotas for imports of products in the poultrymeat sector. The applications for import licences lodged during the first seven days of October 2013 for the subperiod 1 January to 31 March 2014 are, for quotas 09.4212, 09.4217, 09.4218 and 09.4256, for quantities smaller than those available. Pursuant to the second sentence of Article 7(4) of Commission Regulation (EC) No 1301/2006 (2), the quantities that were not applied for are to be added to the quantity fixed for the following quota subperiod, from 1 April to 30 June 2014; they are set out in the Annex to this communication.

---

(1)  OJ L 142, 5.6.2007, p. 3.

(2)  OJ L 238, 1.9.2006, p. 13.

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ANNEX

| Quota order number | Quantities not applied for, to be added to the quantity fixed for the subperiod 1 April to 30 June 2014
  (in kg) |
| --- | --- |
| 09.4212 | 44 864 920 |
| 09.4217 | 12 369 400 |
| 09.4218 | 9 276 800 |
| 09.4256 | 3 245 004 |

Quota order number

Quantities not applied for, to be added to the quantity fixed for the subperiod 1 April to 30 June 2014

(in kg)

09.4212

44 864 920

09.4217

12 369 400

09.4218

9 276 800

09.4256

3 245 004

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

| 7.12.2013 | EN | Official Journal of the European Union | C 358/3 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/3

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COUNCIL DECISION

of 2 December 2013

appointing the members and alternate members of the Advisory Committee on Safety and Health at Work for Croatia, Hungary, Portugal and the United Kingdom

2013/C 358/04

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (1), and in particular Article 3 thereof,

Having regard to the lists of nominations for appointment submitted to the Council by the Governments of the Member States,

Whereas:

| (1) | By its Decision of 22 April 2013 (2), the Council appointed the members and alternate members of the Advisory Committee on Safety and Health at Work for the period from 22 April 2013 to 28 February 2016, with the exception of certain members. |
| --- | --- |

(1)

By its Decision of 22 April 2013 (2), the Council appointed the members and alternate members of the Advisory Committee on Safety and Health at Work for the period from 22 April 2013 to 28 February 2016, with the exception of certain members.

| (2) | The Governments of Croatia, Hungary, Portugal and the United Kingdom have submitted nominations for a number of posts to be filled, |
| --- | --- |

(2)

The Governments of Croatia, Hungary, Portugal and the United Kingdom have submitted nominations for a number of posts to be filled,

HAS ADOPTED THIS DECISION:

Article 1

The following are hereby appointed members and alternate members of the Advisory Committee on Safety and Health at Work for the period ending on 28 February 2016:

I.   GOVERNMENT REPRESENTATIVES

| Country | Member | Alternate |
| --- | --- | --- |
| Croatia | Mr Zdravko MURATTI | Ms Inga ŽIC
  Mr Ilija TADIĆ |
| Portugal | | Mr António SANTOS |

Country

Member

Alternate

Croatia

Mr Zdravko MURATTI

Ms Inga ŽIC

Mr Ilija TADIĆ

Portugal

Mr António SANTOS

II.   TRADE UNION REPRESENTATIVES

| Country | Member | Alternate |
| --- | --- | --- |
| Hungary | Mr Károly GYÖRGY | Mr Szilárd SOMLAI |

Country

Member

Alternate

Hungary

Mr Károly GYÖRGY

Mr Szilárd SOMLAI

III.   EMPLOYERS' REPRESENTATIVES

| Country | Member | Alternate |
| --- | --- | --- |
| Croatia | Ms Admira RIBIČIĊ | Mr Nenad SEIFERT
  Ms Milica JOVANOVIĆ |
| United Kingdom | | Ms Hannah MURPHY |

Country

Member

Alternate

Croatia

Ms Admira RIBIČIĊ

Mr Nenad SEIFERT

Ms Milica JOVANOVIĆ

United Kingdom

Ms Hannah MURPHY

Article 2

The Council will appoint the members and alternate members not yet nominated at a later date.

Article 3

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 2 December 2013.

For the Council

The President

E. GUSTAS

---

(1)  OJ C 218, 13.9.2003, p. 1.

1

(2)  OJ C 120, 26.4.2013, p. 7.

2

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| 7.12.2013 | EN | Official Journal of the European Union | C 358/5 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/5

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COUNCIL DECISION

of 2 December 2013

appointing the members and alternate members of the Governing Board of the European Foundation for the Improvement of Living and Working Conditions

2013/C 358/05

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EEC) No 1365/75 of 26 May 1975 on the creation of a European Foundation for the Improvement of Living and Working Conditions (1), and in particular Article 6 thereof,

Having regard to the lists of nominations for appointment submitted to the Council by the Governments of the Member States and by the employees’ and employers’ organisations,

Whereas:

| (1) | By its Decisions of 22 November 2010 (2), 7 March 2011 (3), 12 July 2011 (4), 20 September 2011 (5) and 29 October 2012 (6), the Council appointed the members and alternate members of the Governing Board of the European Foundation for the Improvement of Living and Working Conditions for the period from 1 December 2010 to 30 November 2013. |
| --- | --- |

(1)

By its Decisions of 22 November 2010 (2), 7 March 2011 (3), 12 July 2011 (4), 20 September 2011 (5) and 29 October 2012 (6), the Council appointed the members and alternate members of the Governing Board of the European Foundation for the Improvement of Living and Working Conditions for the period from 1 December 2010 to 30 November 2013.

| (2) | The members and alternate members of the Governing Board, representing the Governments of the Member States and employees’ and employers’ organisations, should be appointed for a period of three years. |
| --- | --- |

(2)

The members and alternate members of the Governing Board, representing the Governments of the Member States and employees’ and employers’ organisations, should be appointed for a period of three years.

| (3) | It is for the Commission to appoint its own representatives on the Governing Board, |
| --- | --- |

(3)

It is for the Commission to appoint its own representatives on the Governing Board,

HAS ADOPTED THIS DECISION:

Article 1

The following shall be appointed members and alternate members of the Governing Board of the European Foundation for the Improvement of Living and Working Conditions for the period from 1 December 2013 to 30 November 2016:

I.   GOVERNMENT REPRESENTATIVES

| Country | Members | Alternates |
| --- | --- | --- |
| Belgium | Mr Michel DE GOLS | Mr Alain PIETTE |
| Bulgaria | Ms Teodora TODOROVA | Mr Iskren ANGELOV |
| Czech Republic | Mr Vlastimil VÁŇA | Ms Veronika ŽIDLÍKOVÁ |
| Denmark | Ms Lone HENRIKSEN | Ms Lis WITSØ-LUND |
| Germany | Mr Andreas HORST | Mr Sebastian JOBELIUS |
| Estonia | Ms Eva PÕLDIS | Ms Ester RÜNKLA |
| Ireland | Mr Paul CULLEN | Ms Mary O’SULLIVAN |
| Greece | Ms Stamatia PISIMISI | Mr Ioannis KONSTANTAKOPOULOS |
| Croatia | Ms Narcisa MANOJLOVIĆ | Ms Olivera FIŠEKOVIĆ |
| Spain | Ms Paloma GARCÍA GARCÍA | Mr José Ignacio MARTÍN FERNÁNDEZ |
| France | Ms Valérie DELAHAYE-GUILLOCHEAU | Ms Marie-Soline CHOMEL |
| Italy | Ms Aviana Maria Teresa BULGARELLI | Ms Carla ANTONUCCI |
| Cyprus | Mr Andreas MYLONAS | Mr Orestis MESSIOS |
| Latvia | Ms Ineta TĀRE | Ms Ineta VJAKSE |
| Lithuania | Ms Rita SKREBIŠKIENĖ | Mr Evaldas BACEVIČIUS |
| Luxembourg | Ms Nadine WELTER | Mr Gary TUNSCH |
| Hungary | | |
| Malta | Mr Roderick MIZZI | Mr Anthony AZZOPARDI |
| Netherlands | Mr Roel GANS | Mr Martin BLOMSMA |
| Austria | Ms Stephanie MATTES | Ms Petra PENCS |
| Poland | Mr Jerzy CIECHAŃSKI | Ms Joanna MACIEJEWSKA |
| Portugal | Mr Manuel MADURO ROXO | Ms Isilda FERNANDES |
| Romania | Mr Alexandru ALEXE | Ms Liliana Ramona MOȘTENESCU |
| Slovenia | Ms Vladka KOMEL | Mr Andraž BOBOVNIK |
| Slovakia | Ms Silvia GREGORCOVÁ | |
| Finland | Mr Antti NÄRHINEN | Ms Maija LYLY-YRJÄNÄINEN |
| Sweden | Mr Hannes KANTELIUS | Mr Håkan NYMAN |
| United Kingdom | Mr Ciaran DEVLIN | Ms Shyamala BALENDRA |

Country

Members

Alternates

Belgium

Mr Michel DE GOLS

Mr Alain PIETTE

Bulgaria

Ms Teodora TODOROVA

Mr Iskren ANGELOV

Czech Republic

Mr Vlastimil VÁŇA

Ms Veronika ŽIDLÍKOVÁ

Denmark

Ms Lone HENRIKSEN

Ms Lis WITSØ-LUND

Germany

Mr Andreas HORST

Mr Sebastian JOBELIUS

Estonia

Ms Eva PÕLDIS

Ms Ester RÜNKLA

Ireland

Mr Paul CULLEN

Ms Mary O’SULLIVAN

Greece

Ms Stamatia PISIMISI

Mr Ioannis KONSTANTAKOPOULOS

Croatia

Ms Narcisa MANOJLOVIĆ

Ms Olivera FIŠEKOVIĆ

Spain

Ms Paloma GARCÍA GARCÍA

Mr José Ignacio MARTÍN FERNÁNDEZ

France

Ms Valérie DELAHAYE-GUILLOCHEAU

Ms Marie-Soline CHOMEL

Italy

Ms Aviana Maria Teresa BULGARELLI

Ms Carla ANTONUCCI

Cyprus

Mr Andreas MYLONAS

Mr Orestis MESSIOS

Latvia

Ms Ineta TĀRE

Ms Ineta VJAKSE

Lithuania

Ms Rita SKREBIŠKIENĖ

Mr Evaldas BACEVIČIUS

Luxembourg

Ms Nadine WELTER

Mr Gary TUNSCH

Hungary

Malta

Mr Roderick MIZZI

Mr Anthony AZZOPARDI

Netherlands

Mr Roel GANS

Mr Martin BLOMSMA

Austria

Ms Stephanie MATTES

Ms Petra PENCS

Poland

Mr Jerzy CIECHAŃSKI

Ms Joanna MACIEJEWSKA

Portugal

Mr Manuel MADURO ROXO

Ms Isilda FERNANDES

Romania

Mr Alexandru ALEXE

Ms Liliana Ramona MOȘTENESCU

Slovenia

Ms Vladka KOMEL

Mr Andraž BOBOVNIK

Slovakia

Ms Silvia GREGORCOVÁ

Finland

Mr Antti NÄRHINEN

Ms Maija LYLY-YRJÄNÄINEN

Sweden

Mr Hannes KANTELIUS

Mr Håkan NYMAN

United Kingdom

Mr Ciaran DEVLIN

Ms Shyamala BALENDRA

II.   REPRESENTATIVES OF EMPLOYEES’ ORGANISATIONS

| Country | Members | Alternates |
| --- | --- | --- |
| Belgium | Mr Herman FONCK | Mr François PHILIPS |
| Bulgaria | Mr Ivan KOKALOV | Mr Vesselin MITOV |
| Czech Republic | Ms Hana MÁLKOVÁ | Mr Tomáš PAVELKA |
| Denmark | Mr Jan KAHR FREDERIKSEN | Ms Heidi RØNNE MØLLER |
| Germany | Ms Marika HÖHN | Ms Ghazaleh NAZZIBI |
| Estonia | Mr Kalle KALDA | Ms Kadi ALATALU |
| Ireland | Ms Sally Anne KINAHAN | Mr Peter RIGNEY |
| Greece | Mr Panagiotis SYRIOPOULOS | Mr Panagiotis KORDATOS |
| Croatia | Ms Marija HANŽEVAČKI | Ms Dijana ŠOBOTA |
| Spain | Ms Antonia RAMOS YUSTE | Mr Ramon BAEZA |
| France | Mr Emmanuel COUVREUR | Mr Rafaël NEDZYNSKI |
| Italy | Mr Fausto DURANTE | Ms Cinzia DEL RIO |
| Cyprus | Mr Nicolaos EPISTITHIOU | |
| Latvia | Ms Ruta PORNIECE | |
| Lithuania | Ms Kristina KRUPAVIČIENĖ | Ms Danute ŠLIONSKIENĖ |
| Luxembourg | Ms Véronique EISCHEN | Mr Vincent JACQUET |
| Hungary | Ms Melinda KELEMEN | Ms Erzsébet HANTI |
| Malta | | |
| Netherlands | Mr Erik PENTENGA | Ms Sonja BALJEU |
| Austria | Ms Dinah DJALINOUS-GLATZ | Mr Adi BUXBAUM |
| Poland | Mr Bogdan OLSZEWSKI | Mr Piotr OSTROWSKI |
| Portugal | Mr Armando da COSTA FARIAS | Mr Vítor Manuel VICENTE COELHO |
| Romania | Mr Adrian MARIN | Ms Luminița VINTILĂ |
| Slovenia | Mr Pavle VRHOVEC | Ms Maja KONJAR |
| Slovakia | Mr Erik MACÁK | |
| Finland | Mr Juha ANTILA | Ms Leila KURKI |
| Sweden | Mr Mats ESSEMYR | Mr Sten GELLERSTEDT |
| United Kingdom | Mr Paul SELLERS | Ms Elena CRASTA |

Country

Members

Alternates

Belgium

Mr Herman FONCK

Mr François PHILIPS

Bulgaria

Mr Ivan KOKALOV

Mr Vesselin MITOV

Czech Republic

Ms Hana MÁLKOVÁ

Mr Tomáš PAVELKA

Denmark

Mr Jan KAHR FREDERIKSEN

Ms Heidi RØNNE MØLLER

Germany

Ms Marika HÖHN

Ms Ghazaleh NAZZIBI

Estonia

Mr Kalle KALDA

Ms Kadi ALATALU

Ireland

Ms Sally Anne KINAHAN

Mr Peter RIGNEY

Greece

Mr Panagiotis SYRIOPOULOS

Mr Panagiotis KORDATOS

Croatia

Ms Marija HANŽEVAČKI

Ms Dijana ŠOBOTA

Spain

Ms Antonia RAMOS YUSTE

Mr Ramon BAEZA

France

Mr Emmanuel COUVREUR

Mr Rafaël NEDZYNSKI

Italy

Mr Fausto DURANTE

Ms Cinzia DEL RIO

Cyprus

Mr Nicolaos EPISTITHIOU

Latvia

Ms Ruta PORNIECE

Lithuania

Ms Kristina KRUPAVIČIENĖ

Ms Danute ŠLIONSKIENĖ

Luxembourg

Ms Véronique EISCHEN

Mr Vincent JACQUET

Hungary

Ms Melinda KELEMEN

Ms Erzsébet HANTI

Malta

Netherlands

Mr Erik PENTENGA

Ms Sonja BALJEU

Austria

Ms Dinah DJALINOUS-GLATZ

Mr Adi BUXBAUM

Poland

Mr Bogdan OLSZEWSKI

Mr Piotr OSTROWSKI

Portugal

Mr Armando da COSTA FARIAS

Mr Vítor Manuel VICENTE COELHO

Romania

Mr Adrian MARIN

Ms Luminița VINTILĂ

Slovenia

Mr Pavle VRHOVEC

Ms Maja KONJAR

Slovakia

Mr Erik MACÁK

Finland

Mr Juha ANTILA

Ms Leila KURKI

Sweden

Mr Mats ESSEMYR

Mr Sten GELLERSTEDT

United Kingdom

Mr Paul SELLERS

Ms Elena CRASTA

III.   REPRESENTATIVES OF EMPLOYERS’ ORGANISATIONS

| Country | Members | Alternates |
| --- | --- | --- |
| Belgium | Mr Kris DE MEESTER | Mr Roland WAEYAERT |
| Bulgaria | Mr Dimiter BRANKOV | Mr Nikola ZIKATANOV |
| Czech Republic | Ms Vladimíra DRBALOVÁ | Ms Pavla BŘEČKOVÁ |
| Denmark | Ms Karen ROIY | Ms Berit TOFT FIHL |
| Germany | Mr Lutz MÜHL | Ms Renate HORNUNG-DRAUS |
| Estonia | Ms Eve PÄÄRENDSON | Ms Marika MERILAI |
| Ireland | Mr Brendan McGINTY | Mr Eamonn McCOY |
| Greece | Ms Rena BARDANI | Ms Katerina DASKALAKI |
| Croatia | Mr Davor MAJETIC | Mr Nenad SEIFERT |
| Spain | Mr Miguel CANALES GUTIÉRREZ | Mr Javier BLASCO de LUNA |
| France | Mr Emmanuel JAHAN | |
| Italy | Ms Stefania ROSSI | Ms Paola ASTORRI |
| Cyprus | Ms Lena PANAYIOTOU | Mr Polyvios POLYVIOU |
| Latvia | Ms Ilona KIUKUCĀNE | Ms Anita LĪCE |
| Lithuania | | |
| Luxembourg | Mr Fabio STUPICI | Ms Magalie LYSIAK |
| Hungary | Mr Antal CSUPORT | Ms Adrienn BALINT |
| Malta | Mr Martin BORG | |
| Netherlands | Mr W.M.J.M. VAN MIERLO | Mr Gerard A. M. VAN DER GRIND |
| Austria | Ms Katharina LINDNER | Ms Heidrun MAIER-DE-KRUIJFF |
| Poland | Ms Anna KWIATKIEWICZ | |
| Portugal | Mr Marcelino Peralta PENA COSTA | Mr António VERGUEIRO |
| Romania | Mr Doru Claudian FRUNZULICĂ | Mr Ștefan RĂDEANU |
| Slovenia | Ms Tatjana PAJNKIHAR | Mr Igor ANTAUER |
| Slovakia | Mr Martin HOŠTÁK | |
| Finland | Ms Jenni RUOKONEN | Ms Minna ETU-SEPPÄLÄ |
| Sweden | Mr Sverker RUDEBERG | Mr Niklas BECKMAN |
| United Kingdom | Mr Neil CARBERRY | Mr Rob WALL |

Country

Members

Alternates

Belgium

Mr Kris DE MEESTER

Mr Roland WAEYAERT

Bulgaria

Mr Dimiter BRANKOV

Mr Nikola ZIKATANOV

Czech Republic

Ms Vladimíra DRBALOVÁ

Ms Pavla BŘEČKOVÁ

Denmark

Ms Karen ROIY

Ms Berit TOFT FIHL

Germany

Mr Lutz MÜHL

Ms Renate HORNUNG-DRAUS

Estonia

Ms Eve PÄÄRENDSON

Ms Marika MERILAI

Ireland

Mr Brendan McGINTY

Mr Eamonn McCOY

Greece

Ms Rena BARDANI

Ms Katerina DASKALAKI

Croatia

Mr Davor MAJETIC

Mr Nenad SEIFERT

Spain

Mr Miguel CANALES GUTIÉRREZ

Mr Javier BLASCO de LUNA

France

Mr Emmanuel JAHAN

Italy

Ms Stefania ROSSI

Ms Paola ASTORRI

Cyprus

Ms Lena PANAYIOTOU

Mr Polyvios POLYVIOU

Latvia

Ms Ilona KIUKUCĀNE

Ms Anita LĪCE

Lithuania

Luxembourg

Mr Fabio STUPICI

Ms Magalie LYSIAK

Hungary

Mr Antal CSUPORT

Ms Adrienn BALINT

Malta

Mr Martin BORG

Netherlands

Mr W.M.J.M. VAN MIERLO

Mr Gerard A. M. VAN DER GRIND

Austria

Ms Katharina LINDNER

Ms Heidrun MAIER-DE-KRUIJFF

Poland

Ms Anna KWIATKIEWICZ

Portugal

Mr Marcelino Peralta PENA COSTA

Mr António VERGUEIRO

Romania

Mr Doru Claudian FRUNZULICĂ

Mr Ștefan RĂDEANU

Slovenia

Ms Tatjana PAJNKIHAR

Mr Igor ANTAUER

Slovakia

Mr Martin HOŠTÁK

Finland

Ms Jenni RUOKONEN

Ms Minna ETU-SEPPÄLÄ

Sweden

Mr Sverker RUDEBERG

Mr Niklas BECKMAN

United Kingdom

Mr Neil CARBERRY

Mr Rob WALL

Article 2

The Council will appoint the members and alternate members not yet nominated at a later date.

Article 3

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 2 December 2013.

For the Council

The President

E. GUSTAS

---

(1)  OJ L 139, 30.5.1975, p. 1.

1

(2)  OJ C 322, 27.11.2010, p. 8.

2

(3)  OJ C 83, 17.3.2011, p. 4.

3

(4)  OJ C 208, 14.7.2011, p. 3.

4

(5)  OJ C 278, 22.9.2011, p. 2.

5

(6)  OJ C 334, 31.10.2012, p. 2.

6

---

European Commission

| 7.12.2013 | EN | Official Journal of the European Union | C 358/9 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/9

---

Euro exchange rates (1)

6 December 2013

2013/C 358/06

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3661 |
| JPY | Japanese yen | 139,63 |
| DKK | Danish krone | 7,4600 |
| GBP | Pound sterling | 0,83580 |
| SEK | Swedish krona | 8,9261 |
| CHF | Swiss franc | 1,2231 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,4340 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 27,480 |
| HUF | Hungarian forint | 302,25 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7030 |
| PLN | Polish zloty | 4,1938 |
| RON | Romanian leu | 4,4610 |
| TRY | Turkish lira | 2,7876 |
| AUD | Australian dollar | 1,5065 |
| CAD | Canadian dollar | 1,4548 |
| HKD | Hong Kong dollar | 10,5937 |
| NZD | New Zealand dollar | 1,6663 |
| SGD | Singapore dollar | 1,7119 |
| KRW | South Korean won | 1 444,01 |
| ZAR | South African rand | 14,3055 |
| CNY | Chinese yuan renminbi | 8,3103 |
| HRK | Croatian kuna | 7,6425 |
| IDR | Indonesian rupiah | 16 298,17 |
| MYR | Malaysian ringgit | 4,4192 |
| PHP | Philippine peso | 60,139 |
| RUB | Russian rouble | 45,0410 |
| THB | Thai baht | 44,133 |
| BRL | Brazilian real | 3,2237 |
| MXN | Mexican peso | 17,8348 |
| INR | Indian rupee | 84,1550 |

Currency

Exchange rate

USD

US dollar

1,3661

JPY

Japanese yen

139,63

DKK

Danish krone

7,4600

GBP

Pound sterling

0,83580

SEK

Swedish krona

8,9261

CHF

Swiss franc

1,2231

ISK

Iceland króna

NOK

Norwegian krone

8,4340

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

27,480

HUF

Hungarian forint

302,25

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7030

PLN

Polish zloty

4,1938

RON

Romanian leu

4,4610

TRY

Turkish lira

2,7876

AUD

Australian dollar

1,5065

CAD

Canadian dollar

1,4548

HKD

Hong Kong dollar

10,5937

NZD

New Zealand dollar

1,6663

SGD

Singapore dollar

1,7119

KRW

South Korean won

1 444,01

ZAR

South African rand

14,3055

CNY

Chinese yuan renminbi

8,3103

HRK

Croatian kuna

7,6425

IDR

Indonesian rupiah

16 298,17

MYR

Malaysian ringgit

4,4192

PHP

Philippine peso

60,139

RUB

Russian rouble

45,0410

THB

Thai baht

44,133

BRL

Brazilian real

3,2237

MXN

Mexican peso

17,8348

INR

Indian rupee

84,1550

---

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

---

European Data Protection Supervisor

| 7.12.2013 | EN | Official Journal of the European Union | C 358/10 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/10

---

Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposals for a regulation on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and regulation (EC) No 1223/2009 and a regulation on in vitro diagnostic medical devices

(The full text of this Opinion can be found in English, French and German on the EDPS website: http://www.edps.europa.eu)

2013/C 358/07

1.   Introduction

1.1.   Consultation of the EDPS

| 1. | On 26 September 2012, the Commission adopted two proposals for a regulations on medical devices (‘the proposed MD Regulation’) (1), and a regulation on in vitro diagnostic medical devices (‘the proposed IVD regulation’) (2). These proposals were sent to the EDPS for consultation on 2 October 2012. |
| --- | --- |

1.

On 26 September 2012, the Commission adopted two proposals for a regulations on medical devices (‘the proposed MD Regulation’) (1), and a regulation on in vitro diagnostic medical devices (‘the proposed IVD regulation’) (2). These proposals were sent to the EDPS for consultation on 2 October 2012.

| 2. | The EDPS welcomes the fact that he is consulted by the Commission and recommends that a reference to the consultation be included in the preambles of the proposed regulations. |
| --- | --- |

2.

The EDPS welcomes the fact that he is consulted by the Commission and recommends that a reference to the consultation be included in the preambles of the proposed regulations.

1.2.   Objectives and scope of the proposed regulation

| 3. | The proposed regulations aim at ensuring the safety of medical devices (‘MDs’) (3) and in vitro diagnostic medical devices (‘IVDs’) (4) and their free circulation within the internal market. They amend and clarify the scope of the existing legislation, to take into account scientific and technological progress. The proposed regulations contain legal frameworks to utilise an existing electronic database (Eudamed database) (5) at EU level to facilitate coordination between authorities to ensure rapid and consistent responses to safety issues, to increase devices traceability throughout the supply chain and to clarify the obligations and responsibilities of manufacturers, importers and distributors. They furthermore strengthen the different levels of supervision by clarifying and enhancing the position and powers of public authorities vis-à-vis economic actors. |
| --- | --- |

3.

The proposed regulations aim at ensuring the safety of medical devices (‘MDs’) (3) and in vitro diagnostic medical devices (‘IVDs’) (4) and their free circulation within the internal market. They amend and clarify the scope of the existing legislation, to take into account scientific and technological progress. The proposed regulations contain legal frameworks to utilise an existing electronic database (Eudamed database) (5) at EU level to facilitate coordination between authorities to ensure rapid and consistent responses to safety issues, to increase devices traceability throughout the supply chain and to clarify the obligations and responsibilities of manufacturers, importers and distributors. They furthermore strengthen the different levels of supervision by clarifying and enhancing the position and powers of public authorities vis-à-vis economic actors.

1.3.   Aim of the EDPS Opinion

| 4. | The proposed regulations will affect the rights of individuals related to the processing of their personal data. Amongst other issues, they deal with the processing of sensitive data (health data), a central EU-level database which includes personal data, market surveillance (6) and record keeping. |
| --- | --- |

4.

The proposed regulations will affect the rights of individuals related to the processing of their personal data. Amongst other issues, they deal with the processing of sensitive data (health data), a central EU-level database which includes personal data, market surveillance (6) and record keeping.

| 5. | The EDPS welcomes that the Commission has made an effort to guarantee the correct application of EU rules concerning the protection of personal data in the proposed regulations. However, the EDPS sees a need for some clarifications with particular regards to sensitive data, especially when this category of personal data comes to the processing and storage in the database suggested by the proposed regulations. Indeed, the EDPS has identified certain ambiguities and inconsistencies in the way the proposed regulations deal with the issue of whether and what categories of personal data will be processed, in particular where sensitive data regarding health might be processed and stored. |
| --- | --- |

5.

The EDPS welcomes that the Commission has made an effort to guarantee the correct application of EU rules concerning the protection of personal data in the proposed regulations. However, the EDPS sees a need for some clarifications with particular regards to sensitive data, especially when this category of personal data comes to the processing and storage in the database suggested by the proposed regulations. Indeed, the EDPS has identified certain ambiguities and inconsistencies in the way the proposed regulations deal with the issue of whether and what categories of personal data will be processed, in particular where sensitive data regarding health might be processed and stored.

3.   Conclusions

| 40. | The EDPS welcomes the attention paid specifically to data protection in the proposed regulations, but identified some scope for further improvement. |
| --- | --- |

40.

The EDPS welcomes the attention paid specifically to data protection in the proposed regulations, but identified some scope for further improvement.

| 41. | The EDPS recommends:






  — | that Article 85 of the proposed MD Regulation and Article 81 of the proposed IVD Regulation clarify the reference to Directive 95/46/EC by specifying that the provisions will apply in accordance with the national rules which implement Directive 95/46/EC, |
| --- | --- | --- |

41.

The EDPS recommends:

—

that Article 85 of the proposed MD Regulation and Article 81 of the proposed IVD Regulation clarify the reference to Directive 95/46/EC by specifying that the provisions will apply in accordance with the national rules which implement Directive 95/46/EC,

| — | inserting in Article 85 of the proposed MD Regulation and in Article 81 of the proposed IVD Regulation explicit reference to Article 8 of Directive 95/46/EC and Article 10 of Regulation (EC) No 45/2001, |
| --- | --- |

—

inserting in Article 85 of the proposed MD Regulation and in Article 81 of the proposed IVD Regulation explicit reference to Article 8 of Directive 95/46/EC and Article 10 of Regulation (EC) No 45/2001,

| — | inserting similar paragraphs regarding purposes for data processing, data subject rights and data retention periods as in Article 27 of the proposed MD Regulation into Article 25 of the proposed IVD Regulation, subject to the modifications suggested in this Opinion, |
| --- | --- |

—

inserting similar paragraphs regarding purposes for data processing, data subject rights and data retention periods as in Article 27 of the proposed MD Regulation into Article 25 of the proposed IVD Regulation, subject to the modifications suggested in this Opinion,

| — | including a definition of the term ‘subject’ in the proposed regulations, |
| --- | --- |

—

including a definition of the term ‘subject’ in the proposed regulations,

| — | unambiguously preventing the inclusion of all patients' health data in the clinical investigations module of the Eudamed database, |
| --- | --- |

—

unambiguously preventing the inclusion of all patients' health data in the clinical investigations module of the Eudamed database,

| — | inserting provisions in the proposed MD Regulation and the proposed IVD Regulation that clearly define in which situations and subject to which safeguards information containing patient health data will be processed and stored in the Eudamed database concerning vigilance and post-market surveillance. In particular, the proposed regulation should require that a risk assessment be carried out by the Commission before the processing and storage of any patient health data in the Eudamed database, |
| --- | --- |

—

inserting provisions in the proposed MD Regulation and the proposed IVD Regulation that clearly define in which situations and subject to which safeguards information containing patient health data will be processed and stored in the Eudamed database concerning vigilance and post-market surveillance. In particular, the proposed regulation should require that a risk assessment be carried out by the Commission before the processing and storage of any patient health data in the Eudamed database,

| — | including, in a recital of both proposed regulations, that any implementing measures to be adopted under the proposed regulations should specify in detail the data protection implications of the functional and technical characteristics of the Eudamed database and the EDPS should be consulted, |
| --- | --- |

—

including, in a recital of both proposed regulations, that any implementing measures to be adopted under the proposed regulations should specify in detail the data protection implications of the functional and technical characteristics of the Eudamed database and the EDPS should be consulted,

| — | explicitly mentioning that periodic reports in Article 61 of the proposed MD Regulation and Article 59 of the proposed IVD Regulation should only be using anonymous data, |
| --- | --- |

—

explicitly mentioning that periodic reports in Article 61 of the proposed MD Regulation and Article 59 of the proposed IVD Regulation should only be using anonymous data,

| — | adding the following sentence to Article 8(6) of both proposed regulations: ‘Before any processing of data concerning health of patients takes place, manufacturers shall obtain explicit consent from the data subject pursuant to Article 8(2)(a) of Directive 95/46/EC.’, |
| --- | --- |

—

adding the following sentence to Article 8(6) of both proposed regulations: ‘Before any processing of data concerning health of patients takes place, manufacturers shall obtain explicit consent from the data subject pursuant to Article 8(2)(a) of Directive 95/46/EC.’,

| — | inserting provisions regulating how personal data should be managed as regards the surveillance by competent authorities in the proposed regulations, |
| --- | --- |

—

inserting provisions regulating how personal data should be managed as regards the surveillance by competent authorities in the proposed regulations,

| — | inserting a maximum retention period for personal data under the proposed regulations. The chosen period should be necessary and proportionate for the purposes for which personal data are collected and processed. |
| --- | --- |

—

inserting a maximum retention period for personal data under the proposed regulations. The chosen period should be necessary and proportionate for the purposes for which personal data are collected and processed.

| — | consulting the EDPS in relation to any delegated or implementing act adopted pursuant to the proposed regulations which might have an impact on the processing of personal data. |
| --- | --- |

—

consulting the EDPS in relation to any delegated or implementing act adopted pursuant to the proposed regulations which might have an impact on the processing of personal data.

Done at Brussels, 8 February 2013.

Giovanni BUTTARELLI

Assistant European Data Protection Supervisor

---

(1)  COM(2012) 542 final.

1

(2)  COM(2012) 541 final.

2

(3)  Medical devices include products such as sticking plasters, contact lenses, dental filling materials, x-ray machines, pacemakers, breast implants or hip replacements.

3

(4)  In vitro diagnostic medical devices include products such as devices used to ensure the safety of blood transfusion (e.g. blood grouping), detect infectious diseases (e.g. HIV), monitor diseases (e.g. diabetes) and perform blood chemistry (e.g. cholesterol measurement).

4

(5)  Established by Commission Decision 2010/227/EU (OJ L 102, 23.4.2010, p. 45).

5

(6)  For example regarding the market surveillance plan, where manufacturers are required to institute and keep up to date a systematic procedure to collect and review experience gained from devices placed on the market. This would entail the collection, recording and investigation of complaints and reports from healthcare professionals, patients or users on suspected incidents related to devices.

6

---

| 7.12.2013 | EN | Official Journal of the European Union | C 358/13 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/13

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Executive summary of the Opinion of the European Data Protection Supervisor on the Communication from the Commission on ‘eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century’

(The full text of this Opinion can be found in English, French and German on the EDPS website http://www.edps.europa.eu)

2013/C 358/08

1.   Introduction

1.1.   Consultation of the EDPS

| 1. | On 6 December 2012, the Commission adopted a Communication on the ‘eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century’ (the Communication) (1). This proposal was sent to the EDPS for consultation on 7 December 2012. |
| --- | --- |

1.

On 6 December 2012, the Commission adopted a Communication on the ‘eHealth Action Plan 2012-2020 — Innovative healthcare for the 21st century’ (the Communication) (1). This proposal was sent to the EDPS for consultation on 7 December 2012.

| 2. | Before the adoption of the Communication, the EDPS was given the possibility to provide informal comments to the Commission. He welcomes that some of his comments have been taken into account in the Communication. |
| --- | --- |

2.

Before the adoption of the Communication, the EDPS was given the possibility to provide informal comments to the Commission. He welcomes that some of his comments have been taken into account in the Communication.

1.2.   Objectives and scope of the Communication and aim of the EDPS Opinion

| 3. | The Communication establishes an eHealth Action Plan for 2012-2020. The Action Plan presents the view that information and communication technologies (ICT) applied to healthcare and well-being can improve the efficiency and effectiveness of healthcare systems, empower the individual citizen and unlock innovation in the health and well-being markets. |
| --- | --- |

3.

The Communication establishes an eHealth Action Plan for 2012-2020. The Action Plan presents the view that information and communication technologies (ICT) applied to healthcare and well-being can improve the efficiency and effectiveness of healthcare systems, empower the individual citizen and unlock innovation in the health and well-being markets.

| 4. | This EDPS Opinion is to be seen in the light of the growing importance of eHealth in the evolving information society and of the ongoing policy debate within the EU on eHealth. The Opinion focuses especially on the implications of the fundamental right to data protection for eHealth initiatives. It also comments on the areas for further action identified in the Communication. |
| --- | --- |

4.

This EDPS Opinion is to be seen in the light of the growing importance of eHealth in the evolving information society and of the ongoing policy debate within the EU on eHealth. The Opinion focuses especially on the implications of the fundamental right to data protection for eHealth initiatives. It also comments on the areas for further action identified in the Communication.

3.   Conclusions

| 33. | The EDPS welcomes the attention paid specifically to data protection in the proposed Communication, but identified some scope for further improvement. |
| --- | --- |

33.

The EDPS welcomes the attention paid specifically to data protection in the proposed Communication, but identified some scope for further improvement.

| 34. | The EDPS underlines that data protection requirements should be appropriately considered by industry, Member States and the Commission when implementing initiatives within the eHealth area. In particular he:






  — | emphasizes that personal data processed in the context of eHealth and well-being ICT often relate to health data, which require a higher level of data protection and underlines the guidance already given to controllers and processors in the area, |
| --- | --- | --- |

34.

The EDPS underlines that data protection requirements should be appropriately considered by industry, Member States and the Commission when implementing initiatives within the eHealth area. In particular he:

—

emphasizes that personal data processed in the context of eHealth and well-being ICT often relate to health data, which require a higher level of data protection and underlines the guidance already given to controllers and processors in the area,

| — | notes that the Communication does not refer to the current data protection legal framework set forth under Directive 95/46/EC and Directive 2002/58/EC, which contains the relevant data protection principles that are currently applicable and reminds the Commission that these rules are to be respected for any action to be taken in the short to medium term until the proposed revised data protection regulation enters into force, |
| --- | --- |

—

notes that the Communication does not refer to the current data protection legal framework set forth under Directive 95/46/EC and Directive 2002/58/EC, which contains the relevant data protection principles that are currently applicable and reminds the Commission that these rules are to be respected for any action to be taken in the short to medium term until the proposed revised data protection regulation enters into force,

| — | notes that the importance of the data subject's rights of access and information in the context of eHealth has not been made clear in the Communication. He therefore encourages the Commission to draw the attention of controllers active in the field of eHealth on the necessity to provide clear information to individuals about the processing of their personal data in eHealth applications, |
| --- | --- |

—

notes that the importance of the data subject's rights of access and information in the context of eHealth has not been made clear in the Communication. He therefore encourages the Commission to draw the attention of controllers active in the field of eHealth on the necessity to provide clear information to individuals about the processing of their personal data in eHealth applications,

| — | notes that the availability of guidance in respect of eHealth processing operations taking place under the current legal framework has not been emphasized in the Communication with specific references to the relevant documents and recommends that the Commission consults the Article 29 Working Party, in which the EU national data protection authorities are represented, and the EDPS in the preparation of such guidance, |
| --- | --- |

—

notes that the availability of guidance in respect of eHealth processing operations taking place under the current legal framework has not been emphasized in the Communication with specific references to the relevant documents and recommends that the Commission consults the Article 29 Working Party, in which the EU national data protection authorities are represented, and the EDPS in the preparation of such guidance,

| — | recommends consulting the EDPS before the adoption by the Commission of a green paper on an EU framework applicable to mHealth and health and well-being mobile apps, |
| --- | --- |

—

recommends consulting the EDPS before the adoption by the Commission of a green paper on an EU framework applicable to mHealth and health and well-being mobile apps,

| — | notes that the Communication does not underline that any data mining using non-anonymous health data is only acceptable under very limited circumstances and provided that full account is taken of data protection rules and encourages the Commission to draw the attention of controllers to this fact, |
| --- | --- |

—

notes that the Communication does not underline that any data mining using non-anonymous health data is only acceptable under very limited circumstances and provided that full account is taken of data protection rules and encourages the Commission to draw the attention of controllers to this fact,

| — | underlines that profiling should only be done in very limited circumstances and provided that strict data protection requirements must be met (e.g. as set forth in Article 20 of the proposed data protection regulation) and encourages the Commission to remind controllers of this important obligation, |
| --- | --- |

—

underlines that profiling should only be done in very limited circumstances and provided that strict data protection requirements must be met (e.g. as set forth in Article 20 of the proposed data protection regulation) and encourages the Commission to remind controllers of this important obligation,

| — | reminds the Commission that any future work in the areas of facilitating wider deployment, supporting user skills and literacy should be pursued in due observance of the principles of data protection, |
| --- | --- |

—

reminds the Commission that any future work in the areas of facilitating wider deployment, supporting user skills and literacy should be pursued in due observance of the principles of data protection,

| — | recommends that the Commission carries out a data protection impact assessment in the context of the development of a common European eHealth Interoperability Framework, before any further action is undertaken, |
| --- | --- |

—

recommends that the Commission carries out a data protection impact assessment in the context of the development of a common European eHealth Interoperability Framework, before any further action is undertaken,

| — | urges the Commission, when examining the interoperability of health records, to look into possible legislative initiatives at EU level, as he believes that such interoperability would benefit from a strong legal basis, which would include specific data protection safeguards. |
| --- | --- |

—

urges the Commission, when examining the interoperability of health records, to look into possible legislative initiatives at EU level, as he believes that such interoperability would benefit from a strong legal basis, which would include specific data protection safeguards.

Done at Brussels, 27 March 2013.

Giovanni BUTTARELLI

Assistant European Data Protection Supervisor

---

(1)  COM(2012) 736 final.

1

---

| 7.12.2013 | EN | Official Journal of the European Union | C 358/15 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/15

---

Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposal for a Regulation amending Council Regulation (EC) No 1346/2000 on insolvency proceedings

(The full text of this Opinion can be found in English, French and German on the EDPS website http://www.edps.europa.eu)

2013/C 358/09

1.   Introduction

1.1.   Consultation of the EDPS

| 1. | On 12 December 2012, the Commission adopted a proposal for a Regulation amending Council Regulation (EC) No 1346/2000 on insolvency proceedings (‘the proposed Regulation’) (1). This Proposal was sent to the EDPS for consultation on 13 December 2012. |
| --- | --- |

1.

On 12 December 2012, the Commission adopted a proposal for a Regulation amending Council Regulation (EC) No 1346/2000 on insolvency proceedings (‘the proposed Regulation’) (1). This Proposal was sent to the EDPS for consultation on 13 December 2012.

| 2. | The EDPS welcomes the fact that he is consulted by the Commission and that a reference to this Opinion is included in the preambles of the proposed legal instrument. |
| --- | --- |

2.

The EDPS welcomes the fact that he is consulted by the Commission and that a reference to this Opinion is included in the preambles of the proposed legal instrument.

| 3. | Before the adoption of the proposed Regulation, the EDPS was given the opportunity to provide informal comments to the Commission. |
| --- | --- |

3.

Before the adoption of the proposed Regulation, the EDPS was given the opportunity to provide informal comments to the Commission.

| 4. | The EDPS regrets that only a few of his comments have been taken into account in the proposed Regulation. Even though an article is now dedicated to data protection, safeguards have not been strengthened accordingly. |
| --- | --- |

4.

The EDPS regrets that only a few of his comments have been taken into account in the proposed Regulation. Even though an article is now dedicated to data protection, safeguards have not been strengthened accordingly.

1.2.   Objectives and scope of the proposed Regulation

| 5. | The proposed Regulation amends the Insolvency Regulation in order to cope with weaknesses revealed in its practical application (2). It inter alia addresses issues relating to the scope of the Regulation, the determination of the Member State competent to open the proceedings, the opening of secondary proceedings and the rules on publicity of decisions opening and closing insolvency proceedings. |
| --- | --- |

5.

The proposed Regulation amends the Insolvency Regulation in order to cope with weaknesses revealed in its practical application (2). It inter alia addresses issues relating to the scope of the Regulation, the determination of the Member State competent to open the proceedings, the opening of secondary proceedings and the rules on publicity of decisions opening and closing insolvency proceedings.

| 6. | Amongst the measures proposed that will impact data protection, the Proposal provides for a mandatory publication of the decisions opening or closing a proceeding and encourages and organises cross-boarder exchanges of information between stakeholders. |
| --- | --- |

6.

Amongst the measures proposed that will impact data protection, the Proposal provides for a mandatory publication of the decisions opening or closing a proceeding and encourages and organises cross-boarder exchanges of information between stakeholders.

| 7. | Information thus published and/or exchanged may identify (either directly or indirectly) debtors, creditors, and liquidators involved in the proceeding. Therefore, EU data protection legislation applies. In particular, Directive 95/46/EC will apply to the processing of data by stakeholders in Member States and by national competent authorities, while Regulation (EC) No 45/2001 will apply to the processing of data by the Commission through the e-Justice Portal. |
| --- | --- |

7.

Information thus published and/or exchanged may identify (either directly or indirectly) debtors, creditors, and liquidators involved in the proceeding. Therefore, EU data protection legislation applies. In particular, Directive 95/46/EC will apply to the processing of data by stakeholders in Member States and by national competent authorities, while Regulation (EC) No 45/2001 will apply to the processing of data by the Commission through the e-Justice Portal.

1.3.   Aim of the EDPS Opinion

| 8. | The proposed Regulation may affect the rights of individuals related to the processing of their personal data as, amongst other issues, it deals with the publication of personal data in a register accessible to the public on the Internet, free of charge, with the interconnection of existing national registers and with cross border exchange of information between stakeholders. |
| --- | --- |

8.

The proposed Regulation may affect the rights of individuals related to the processing of their personal data as, amongst other issues, it deals with the publication of personal data in a register accessible to the public on the Internet, free of charge, with the interconnection of existing national registers and with cross border exchange of information between stakeholders.

| 9. | Although the EDPS welcomes the effort made by the Commission to guarantee the correct application of EU rules concerning the protection of personal data in the proposed Regulation, he has identified some shortcomings and inconsistencies in the way the proposed Regulation deals with issues related to/concerning personal data. |
| --- | --- |

9.

Although the EDPS welcomes the effort made by the Commission to guarantee the correct application of EU rules concerning the protection of personal data in the proposed Regulation, he has identified some shortcomings and inconsistencies in the way the proposed Regulation deals with issues related to/concerning personal data.

3.   Conclusions

| 54. | The EDPS welcomes the attention paid specifically to data protection in the proposed Regulation, but identified some scope for further improvement. |
| --- | --- |

54.

The EDPS welcomes the attention paid specifically to data protection in the proposed Regulation, but identified some scope for further improvement.

| 55. | The EDPS recommends that:






  — | references to this Opinion are included in the preambles of all proposals, |
| --- | --- | --- |

55.

The EDPS recommends that:

—

references to this Opinion are included in the preambles of all proposals,

| — | Article 46(a) of the proposed Regulation clarifies the reference to Directive 95/46/EC by specifying that the provisions will apply in accordance with the national rules which implement Directive 95/46/EC, |
| --- | --- |

—

Article 46(a) of the proposed Regulation clarifies the reference to Directive 95/46/EC by specifying that the provisions will apply in accordance with the national rules which implement Directive 95/46/EC,

| — | concrete and effective data protection safeguards are put in place for any situation in which personal data processing is envisaged, |
| --- | --- |

—

concrete and effective data protection safeguards are put in place for any situation in which personal data processing is envisaged,

| — | the necessity and the proportionality of the proposed system for the Internet publication of decisions opening and closing insolvency proceedings is assessed and it is verified whether the publication obligation does not go beyond what is necessary to achieve the public interest objective pursued and whether there are not less restrictive measures to attain the same objective. Subject to the outcome of this proportionality test, the publication obligation should in any event be supported by adequate safeguards to ensure full respect of the rights of the persons concerned, the security/accuracy of the data and their deletion after an adequate period of time. |
| --- | --- |

—

the necessity and the proportionality of the proposed system for the Internet publication of decisions opening and closing insolvency proceedings is assessed and it is verified whether the publication obligation does not go beyond what is necessary to achieve the public interest objective pursued and whether there are not less restrictive measures to attain the same objective. Subject to the outcome of this proportionality test, the publication obligation should in any event be supported by adequate safeguards to ensure full respect of the rights of the persons concerned, the security/accuracy of the data and their deletion after an adequate period of time.

| 56. | The EDPS furthermore recommends that:






  — | the modalities of the functioning of national databases and the EU database with regard to data protection issues are clarified by introducing more detailed provisions in the proposed Regulations, in compliance with Directive 95/46/EC and Regulation (EC) No 45/2001. In particular, the provision establishing the database(s) must (i) identify the purpose of the processing operations and establish which are the compatible uses; (ii) identify which entities (competent authorities, Commission) will have access to which data stored in the database and will have the possibility to modify the data; (iii) ensure the right of access and appropriate information for all the data subjects whose personal data may be stored and exchanged (iv) define and limit the retention period for the personal data to the minimum necessary for the performance of such purpose, |
| --- | --- | --- |

56.

The EDPS furthermore recommends that:

—

the modalities of the functioning of national databases and the EU database with regard to data protection issues are clarified by introducing more detailed provisions in the proposed Regulations, in compliance with Directive 95/46/EC and Regulation (EC) No 45/2001. In particular, the provision establishing the database(s) must (i) identify the purpose of the processing operations and establish which are the compatible uses; (ii) identify which entities (competent authorities, Commission) will have access to which data stored in the database and will have the possibility to modify the data; (iii) ensure the right of access and appropriate information for all the data subjects whose personal data may be stored and exchanged (iv) define and limit the retention period for the personal data to the minimum necessary for the performance of such purpose,

| — | at least core principles of the decentralised system for the interconnection of insolvency registers such as necessity and proportionality are established in the present Proposal (while further safeguards are expected to be provided in the forthcoming Commission's legislative proposal for the e-Justice portal), |
| --- | --- |

—

at least core principles of the decentralised system for the interconnection of insolvency registers such as necessity and proportionality are established in the present Proposal (while further safeguards are expected to be provided in the forthcoming Commission's legislative proposal for the e-Justice portal),

| — | it is specified whether any data will be stored in the e-Justice portal. If this is the case, specific safeguards should be added. |
| --- | --- |

—

it is specified whether any data will be stored in the e-Justice portal. If this is the case, specific safeguards should be added.

Done at Brussels, 27 March 2013.

Giovanni BUTTARELLI

Assistant European Data Protection Supervisor

---

(1)  COM(2012) 744 final.

1

(2)  Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1346/2000 on insolvency proceedings (hereinafter: ‘the Proposal’).

2

---

| 7.12.2013 | EN | Official Journal of the European Union | C 358/17 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/17

---

Executive summary of the Opinion of the European Data Protection Supervisor on the Communication from the Commission on ‘The Digital Agenda for Europe — Driving European growth digitally’

(The full text of this Opinion can be found in English, French and German on the EDPS website http://www.edps.europa.eu)

2013/C 358/10

I.   Introduction

1.1.   Consultation of the EDPS

| 1. | On 18 December 2012, the Commission adopted a Communication on ‘The Digital Agenda for Europe — Driving European growth digitally’ (hereafter ‘the Communication’) (1). |
| --- | --- |

1.

On 18 December 2012, the Commission adopted a Communication on ‘The Digital Agenda for Europe — Driving European growth digitally’ (hereafter ‘the Communication’) (1).

| 2. | Before the adoption of the Communication, the EDPS was given the possibility to provide informal comments to the Commission. He welcomes that some of his comments have been taken into account in the Communication. |
| --- | --- |

2.

Before the adoption of the Communication, the EDPS was given the possibility to provide informal comments to the Commission. He welcomes that some of his comments have been taken into account in the Communication.

| 3. | In the light of the importance of the subject, the EDPS has decided to adopt this Opinion on his own initiative. |
| --- | --- |

3.

In the light of the importance of the subject, the EDPS has decided to adopt this Opinion on his own initiative.

1.2.   Objectives and scope of the Communication and aim of the EDPS Opinion

| 4. | The Communication is put forward by the Commission as part of the Europe 2020 Strategy. It complements the Digital Agenda adopted on 19 May 2010 (2). The objective of this new Communication on the Digital Agenda is to further strengthen European digital leadership and to help complete the Digital Single Market by 2015. |
| --- | --- |

4.

The Communication is put forward by the Commission as part of the Europe 2020 Strategy. It complements the Digital Agenda adopted on 19 May 2010 (2). The objective of this new Communication on the Digital Agenda is to further strengthen European digital leadership and to help complete the Digital Single Market by 2015.

| 5. | The Communication identifies seven key policy areas where the Commission will be deploying particular efforts to enable and stimulate the development of the digital economy:






  — | A European borderless economy — the Digital Single Market |
| --- | --- | --- |

5.

The Communication identifies seven key policy areas where the Commission will be deploying particular efforts to enable and stimulate the development of the digital economy:

—

A European borderless economy — the Digital Single Market

| — | Speeding up public sector innovation |
| --- | --- |

—

Speeding up public sector innovation

| — | Very fast internet supply and demand |
| --- | --- |

—

Very fast internet supply and demand

| — | Cloud computing |
| --- | --- |

—

Cloud computing

| — | Trust and security |
| --- | --- |

—

Trust and security

| — | Entrepreneurship and digital jobs and skills |
| --- | --- |

—

Entrepreneurship and digital jobs and skills

| — | Beyond R&D&I (3): An industrial agenda for key enabling technologies |
| --- | --- |

—

Beyond R&D&I (3): An industrial agenda for key enabling technologies

| 6. | The EDPS welcomes the proposed policy actions aimed to stimulate the use of new technologies by businesses and individuals. The EDPS however underlines that these measures must be accompanied by appropriate activities to ensure the respect of data protection and privacy. |
| --- | --- |

6.

The EDPS welcomes the proposed policy actions aimed to stimulate the use of new technologies by businesses and individuals. The EDPS however underlines that these measures must be accompanied by appropriate activities to ensure the respect of data protection and privacy.

| 7. | Some of the main data protection challenges raised in the context of the EU policy actions in the field of the Digital Agenda have already been underlined and analysed by the EDPS in his Opinion of 18 March 2010 in relation to the 2010 Communication on the Digital Agenda (4). The EDPS particularly emphasised the need to embed privacy by design and privacy by default in the design of new ICT. In this Opinion, the EDPS will therefore focus on providing comments on the areas for further action identified in the Communication. |
| --- | --- |

7.

Some of the main data protection challenges raised in the context of the EU policy actions in the field of the Digital Agenda have already been underlined and analysed by the EDPS in his Opinion of 18 March 2010 in relation to the 2010 Communication on the Digital Agenda (4). The EDPS particularly emphasised the need to embed privacy by design and privacy by default in the design of new ICT. In this Opinion, the EDPS will therefore focus on providing comments on the areas for further action identified in the Communication.

III.   Conclusions

| 26. | The EDPS welcomes that some attention has been given to privacy and data protection in the Communication. However, the EDPS underlines that data protection requirements should receive appropriate consideration from industry, Member States and the Commission when implementing initiatives foreseen in the Digital Agenda. In particular he:






  — | regrets that the Communication did not put any prominent emphasis in its introduction on the importance of the respect of privacy and data protection in the deployment of the actions foreseen therein. He therefore draws the attention of data controllers on the necessity to respect privacy and data protection rules in the design and deployment of new ICT for the digital environment; |
| --- | --- | --- |

26.

The EDPS welcomes that some attention has been given to privacy and data protection in the Communication. However, the EDPS underlines that data protection requirements should receive appropriate consideration from industry, Member States and the Commission when implementing initiatives foreseen in the Digital Agenda. In particular he:

—

regrets that the Communication did not put any prominent emphasis in its introduction on the importance of the respect of privacy and data protection in the deployment of the actions foreseen therein. He therefore draws the attention of data controllers on the necessity to respect privacy and data protection rules in the design and deployment of new ICT for the digital environment;

| — | regrets that the Communication did not refer to the current data protection legal framework set forth under Directive 95/46/EC and Directive 2002/58/EC, and to the proposal for a general Data Protection Regulation, which contain the relevant rules and principles to be taken into account for the deployment of ICT in the digital environment; |
| --- | --- |

—

regrets that the Communication did not refer to the current data protection legal framework set forth under Directive 95/46/EC and Directive 2002/58/EC, and to the proposal for a general Data Protection Regulation, which contain the relevant rules and principles to be taken into account for the deployment of ICT in the digital environment;

| — | regrets that the principle of ‘privacy by design’, which would become a legal obligation under Article 23 of the proposed Data Protection Regulation, has not been emphasised in the Communication. He therefore reminds controllers and ICT designers of the necessity to embed privacy by design in the development of new ICT for the digital environment; |
| --- | --- |

—

regrets that the principle of ‘privacy by design’, which would become a legal obligation under Article 23 of the proposed Data Protection Regulation, has not been emphasised in the Communication. He therefore reminds controllers and ICT designers of the necessity to embed privacy by design in the development of new ICT for the digital environment;

| — | recommends that R&D instruments are used to increase Europe's capacity to apply the principle of privacy by design in all relevant disciplines and that work programmes and calls for proposals take this objective into account; |
| --- | --- |

—

recommends that R&D instruments are used to increase Europe's capacity to apply the principle of privacy by design in all relevant disciplines and that work programmes and calls for proposals take this objective into account;

| — | underlines that the interoperability of national databases should only be practiced in full respect of data protection principles, in particular purpose limitation. He furthermore reminds the Commission that there should be an appropriate legal basis for the use of interoperability as a means to facilitate data sharing, together with appropriate data protection safeguards; |
| --- | --- |

—

underlines that the interoperability of national databases should only be practiced in full respect of data protection principles, in particular purpose limitation. He furthermore reminds the Commission that there should be an appropriate legal basis for the use of interoperability as a means to facilitate data sharing, together with appropriate data protection safeguards;

| — | recommends consulting the EDPS before the adoption by the Commission of a Recommendation on safeguarding the open internet for consumers; |
| --- | --- |

—

recommends consulting the EDPS before the adoption by the Commission of a Recommendation on safeguarding the open internet for consumers;

| — | reminds controllers and users that, while cloud computing presents specific challenges in terms of data protection, extensive guidance has been provided by data protection authorities on the application of current data protection law and by the EDPS on the impact of the proposed Data Protection Regulation on those challenges. This guidance should be relied upon in order to foster trust from individuals and from customers, which in turn will ensure the successful deployment of these new technological means. |
| --- | --- |

—

reminds controllers and users that, while cloud computing presents specific challenges in terms of data protection, extensive guidance has been provided by data protection authorities on the application of current data protection law and by the EDPS on the impact of the proposed Data Protection Regulation on those challenges. This guidance should be relied upon in order to foster trust from individuals and from customers, which in turn will ensure the successful deployment of these new technological means.

Done at Brussels, 10 April 2013.

Peter HUSTINX

European Data Protection Supervisor

---

(1)  COM(2012) 784 final.

1

(2)  COM(2010) 245 final.

2

(3)  Stands for ‘Research, Development and Innovation’.

3

(4)  See EDPS Opinion on ‘Promoting Trust in the Information Society by Fostering Data Protection and Privacy’, 18 March 2010, available on EDPS website at http://www.edps.europa.eu

4

---

| 7.12.2013 | EN | Official Journal of the European Union | C 358/19 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/19

---

Executive summary of the Opinion of the European Data Protection Supervisor on the Commission Proposal for a Regulation on occurrence reporting in civil aviation and repealing Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007, Commission Regulation (EC) No 1330/2007 and Article 19 of Regulation (EU) No 996/2010

(The full text of this Opinion can be found in English, French and German on the EDPS website http://www.edps.europa.eu)

2013/C 358/11

1.   Introduction

1.1.   Consultation of the EDPS

| 1. | On 18 December 2012, the Commission adopted a Proposal for a Regulation on occurrence reporting in civil aviation and repealing Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007, Commission Regulation (EC) No 1330/2007 and Article 19 of Regulation (EU) No 996/2010 (‘the Proposal’) (1). This Proposal was sent to the EDPS for consultation on 8 January 2013. |
| --- | --- |

1.

On 18 December 2012, the Commission adopted a Proposal for a Regulation on occurrence reporting in civil aviation and repealing Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007, Commission Regulation (EC) No 1330/2007 and Article 19 of Regulation (EU) No 996/2010 (‘the Proposal’) (1). This Proposal was sent to the EDPS for consultation on 8 January 2013.

| 2. | The EDPS welcomes the fact that he is consulted by the Commission and that a reference to this Opinion is included in the Preamble of the Proposal. Before the adoption of the Proposal, the EDPS was given the opportunity to provide informal comments to the Commission. |
| --- | --- |

2.

The EDPS welcomes the fact that he is consulted by the Commission and that a reference to this Opinion is included in the Preamble of the Proposal. Before the adoption of the Proposal, the EDPS was given the opportunity to provide informal comments to the Commission.

1.2.   Objectives and scope of the Proposal

| 3. | The three instruments to be repealed by the Proposal organise occurence reporting in the following way: Directive 2003/42/EC (2) requires each Member State to set up a mandatory occurrence reporting system (hereinafter ‘MORS’). Under this legislation, aviation professionals are obliged to report occurrences (3) in their daily operational work through the system established by their organisation (4). In addition, Member States are requested to collect, store, protect and disseminate among themselves information on occurrences. Two implementing rules complete this legislation: Commission Regulation (EC) No 1321/2007 (5), which establishes a European Central Repository (ECR) regrouping all civil aviation occurrences collected by Member States, and Commission Regulation (EC) No 1330/2007 (6), which lays down rules regarding the dissemination of the information contained in the ECR. |
| --- | --- |

3.

The three instruments to be repealed by the Proposal organise occurence reporting in the following way: Directive 2003/42/EC (2) requires each Member State to set up a mandatory occurrence reporting system (hereinafter ‘MORS’). Under this legislation, aviation professionals are obliged to report occurrences (3) in their daily operational work through the system established by their organisation (4). In addition, Member States are requested to collect, store, protect and disseminate among themselves information on occurrences. Two implementing rules complete this legislation: Commission Regulation (EC) No 1321/2007 (5), which establishes a European Central Repository (ECR) regrouping all civil aviation occurrences collected by Member States, and Commission Regulation (EC) No 1330/2007 (6), which lays down rules regarding the dissemination of the information contained in the ECR.

| 4. | The Proposal builds on Directive 2003/42/EC to improve the existing occurrence reporting systems in civil aviation both at national and European level. Amongst other changes, it proposes the following:






  — | ensuring that all relevant occurrences are reported and that the data reported and stored are complete and of high quality, |
| --- | --- | --- |

4.

The Proposal builds on Directive 2003/42/EC to improve the existing occurrence reporting systems in civil aviation both at national and European level. Amongst other changes, it proposes the following:

—

ensuring that all relevant occurrences are reported and that the data reported and stored are complete and of high quality,

| — | adding a voluntary reporting system to the mandatory system, |
| --- | --- |

—

adding a voluntary reporting system to the mandatory system,

| — | requiring not only Member States but also organisations to report occurrences and to organise the transmission of these reports to the ECR, |
| --- | --- |

—

requiring not only Member States but also organisations to report occurrences and to organise the transmission of these reports to the ECR,

| — | encouraging the reporting through a harmonised protection from hierarchical punishment or prosecution of individuals reporting occurrences, |
| --- | --- |

—

encouraging the reporting through a harmonised protection from hierarchical punishment or prosecution of individuals reporting occurrences,

| — | ensuring adequate access to information contained in the ECR. |
| --- | --- |

—

ensuring adequate access to information contained in the ECR.

1.3.   Aim of the EDPS Opinion

| 5. | It follows from the Proposal that occurrences will be reported by employees to their organisations, who will then store them in a database and report them to national designated competent authorities or to the European Aviation Safety Agency (EASA). These authorities, together with EASA and the Commission, will transfer information on civil aviation occurrences to the ECR, managed by the Commission. In addition, the Commission will process data relating to interested parties requesting access to the information stored in the ECR. |
| --- | --- |

5.

It follows from the Proposal that occurrences will be reported by employees to their organisations, who will then store them in a database and report them to national designated competent authorities or to the European Aviation Safety Agency (EASA). These authorities, together with EASA and the Commission, will transfer information on civil aviation occurrences to the ECR, managed by the Commission. In addition, the Commission will process data relating to interested parties requesting access to the information stored in the ECR.

| 6. | The EDPS acknowledges the fact that the purpose of the Proposal is not to regulate the processing of personal data. However, the information that will be stored, reported and transferred may relate to natural persons who are either directly or indirectly identifiable, such as reporters, third parties involved in the reported occurrence and interested parties applying for access (7). The reported information might not only involve technical problems but also, for instance, violent passengers, crew incapacitation or health incidents (8). |
| --- | --- |

6.

The EDPS acknowledges the fact that the purpose of the Proposal is not to regulate the processing of personal data. However, the information that will be stored, reported and transferred may relate to natural persons who are either directly or indirectly identifiable, such as reporters, third parties involved in the reported occurrence and interested parties applying for access (7). The reported information might not only involve technical problems but also, for instance, violent passengers, crew incapacitation or health incidents (8).

| 7. | Therefore, the present Opinion will analyse the elements of the Proposal which concern the processing of personal data. It builds on a previous EDPS Opinion (9) on one of the Regulations which are being repealed by the Proposal (10). |
| --- | --- |

7.

Therefore, the present Opinion will analyse the elements of the Proposal which concern the processing of personal data. It builds on a previous EDPS Opinion (9) on one of the Regulations which are being repealed by the Proposal (10).

4.   Conclusions

| 46. | The EDPS welcomes the attention paid to the protection of personal data, particularly through the engagement taken to ‘disidentify’ a major part of the data processed under occurrence reporting. However, he reminds that the data processed will still be personal data and thus welcomes the references to the applicability of EU data protection legislation. What is provided for amounts at best to partial anonymisation. |
| --- | --- |

46.

The EDPS welcomes the attention paid to the protection of personal data, particularly through the engagement taken to ‘disidentify’ a major part of the data processed under occurrence reporting. However, he reminds that the data processed will still be personal data and thus welcomes the references to the applicability of EU data protection legislation. What is provided for amounts at best to partial anonymisation.

| 47. | The EDPS recommends clarifying the scope of ‘disidentification’. In particular, he proposes the following improvements to the text:






  — | in the Preamble, clarifying that disidentification in the sense of the Proposal is relative and does not correspond to full anonymisation. In addition, in line with the above recommendations, the Preamble should also explain that disidentification and full anonymisation measures are to be applied in different contexts, |
| --- | --- | --- |

47.

The EDPS recommends clarifying the scope of ‘disidentification’. In particular, he proposes the following improvements to the text:

—

in the Preamble, clarifying that disidentification in the sense of the Proposal is relative and does not correspond to full anonymisation. In addition, in line with the above recommendations, the Preamble should also explain that disidentification and full anonymisation measures are to be applied in different contexts,

| — | in Article 16: specifying that data available to independent handlers should also be disidentified or deleted as soon as possible, unless the necessity of storing the data is justified, e.g., to comply with other legal obligations of the organisations, |
| --- | --- |

—

in Article 16: specifying that data available to independent handlers should also be disidentified or deleted as soon as possible, unless the necessity of storing the data is justified, e.g., to comply with other legal obligations of the organisations,

| — | in order to clarify the scope of disidentification, the EDPS recommends replacing in Articles 16(1) and 16(2) ‘personal data’ by ‘personal details’ and adding a reference to the possibility of identification through technical details, in accordance with Article 2(1), |
| --- | --- |

—

in order to clarify the scope of disidentification, the EDPS recommends replacing in Articles 16(1) and 16(2) ‘personal data’ by ‘personal details’ and adding a reference to the possibility of identification through technical details, in accordance with Article 2(1),

| — | Article 5(6) allows Member States and organisations to establish additional reporting systems. It should be specified that this information should also be disidentified. The EDPS therefore recommends clarifying in Article 16(2) that personal data contained in the safety information collection and processing systems established in accordance with Article 5(6) should also be disidentified, |
| --- | --- |

—

Article 5(6) allows Member States and organisations to establish additional reporting systems. It should be specified that this information should also be disidentified. The EDPS therefore recommends clarifying in Article 16(2) that personal data contained in the safety information collection and processing systems established in accordance with Article 5(6) should also be disidentified,

| — | in Article 13(10): specify that the information should be anonymised (11) before its publication, |
| --- | --- |

—

in Article 13(10): specify that the information should be anonymised (11) before its publication,

| — | in Article 11(4): specify that information made available to interested parties listed in Annex III and not relating to their own equipment, operations or field of activity, should not only be aggregated or disidentified, as requested by Article 11(4), but fully anonymised. |
| --- | --- |

—

in Article 11(4): specify that information made available to interested parties listed in Annex III and not relating to their own equipment, operations or field of activity, should not only be aggregated or disidentified, as requested by Article 11(4), but fully anonymised.

| 48. | The EDPS advises specifying in the Proposal who will be the controller of every database. He also recommends defining in the Annexes I and II, in Article 5(6) all the categories of data to be processed and clarifying Articles 7(1) and 11(1) accordingly. If it is not possible to specify all the occurrences and data fields to be processed according to Articles 7(1), 5(3), 5(6) and 11(1), these Articles should at least mention that additional information not required by the Proposal should not contain special categories of data as defined by Article 8 of Directive 95/46/EC and Article 10 of Regulation (EC) No 45/2001 (‘sensitive data’). |
| --- | --- |

48.

The EDPS advises specifying in the Proposal who will be the controller of every database. He also recommends defining in the Annexes I and II, in Article 5(6) all the categories of data to be processed and clarifying Articles 7(1) and 11(1) accordingly. If it is not possible to specify all the occurrences and data fields to be processed according to Articles 7(1), 5(3), 5(6) and 11(1), these Articles should at least mention that additional information not required by the Proposal should not contain special categories of data as defined by Article 8 of Directive 95/46/EC and Article 10 of Regulation (EC) No 45/2001 (‘sensitive data’).

| 49. | The EDPS also recommends specifying the periods during which data shall be stored in the databases, the rights of data subjects and the security measures to be implemented. |
| --- | --- |

49.

The EDPS also recommends specifying the periods during which data shall be stored in the databases, the rights of data subjects and the security measures to be implemented.

| 50. | In case of transfers to third country organisations or international organisations, these should commit to respect adequate safeguards to be provided in a binding instrument. These safeguards could be based on the data protection principles contained in the Standard Contractual Clauses for the transfers of personal data to third countries adopted by the Commission and could be added in the Annex of the Proposal. |
| --- | --- |

50.

In case of transfers to third country organisations or international organisations, these should commit to respect adequate safeguards to be provided in a binding instrument. These safeguards could be based on the data protection principles contained in the Standard Contractual Clauses for the transfers of personal data to third countries adopted by the Commission and could be added in the Annex of the Proposal.

| 51. | As regards the processing of data of interested parties requesting access to the ECR, the EDPS recommends specifying in the Proposal the data protection measures that will apply to the processing of data relating to third parties (e.g., for how long the data will be stored after access has been granted or denied and who has access to these data). In addition, the form contained in Annex IV should include, apart from the notice on access to information (12), a privacy notice. |
| --- | --- |

51.

As regards the processing of data of interested parties requesting access to the ECR, the EDPS recommends specifying in the Proposal the data protection measures that will apply to the processing of data relating to third parties (e.g., for how long the data will be stored after access has been granted or denied and who has access to these data). In addition, the form contained in Annex IV should include, apart from the notice on access to information (12), a privacy notice.

| 52. | Finally, the necessity of processing sensitive data for any of the grounds contained in Article 8(2-4) of Directive 95/46/EC and Article 10(2-4) of Regulation (EC) No 45/2001 should be justified in the Preamble. The EDPS also recommends adopting additional safeguards as regards the processing of special categories of data, such as stricter security measures, the prohibition to disclose the related categories of data to third parties not subject to EU data protection law and the restriction of its disclosure to other interested parties. In addition, the processing of these categories of data may be subject to prior check by EU national data protection authorities and by the EDPS. |
| --- | --- |

52.

Finally, the necessity of processing sensitive data for any of the grounds contained in Article 8(2-4) of Directive 95/46/EC and Article 10(2-4) of Regulation (EC) No 45/2001 should be justified in the Preamble. The EDPS also recommends adopting additional safeguards as regards the processing of special categories of data, such as stricter security measures, the prohibition to disclose the related categories of data to third parties not subject to EU data protection law and the restriction of its disclosure to other interested parties. In addition, the processing of these categories of data may be subject to prior check by EU national data protection authorities and by the EDPS.

Done at Brussels, 10 April 2013.

Giovanni BUTTARELLI

Assistant European Data Protection Supervisor

---

(1)  COM(2012) 776 final.

1

(2)  Directive 2003/42/EC of the European Parliament and of the Council of 13 June 2003 on occurrence reporting in civil aviation (OJ L 167, 4.7.2003, p. 23).

2

(3)  Occurrences are any significant aviation safety event, including incidents, accidents and serious incidents (See Article 2(8) of the Proposal).

3

(4)  ‘Organisation’ is defined in the proposal as ‘any organisation providing aviation products and/or services and encompasses notably aircraft operators, approved maintenance organisations, organisations responsible for type design and/or manufacture of aircraft, air navigation service providers and certified aerodromes’ (See Article 2(9) of the Proposal).

4

(5)  Commission Regulation (EC) No 1321/2007 of 12 November 2007 laying down implementing rules for the integration into a central repository of information on civil aviation occurrences (OJ L 294, 13.11.2007, p. 3).

5

(6)  Commission Regulation (EC) No 1330/2007 of 24 September 2007 laying down implementing rules for the dissemination to interested parties of information on civil aviation occurrences (OJ L 295, 14.11.2007, p. 7).

6

(7)  See on personal data notably Section 3.1.

7

(8)  See Annex I of the Proposal ‘List of incidents to be reported under the mandatory occurrence reporting system’.

8

(9)  See EDPS Opinion on the proposal for a Regulation of the European Parliament and of the Council on investigation and prevention of accidents and incidents in civil aviation (OJ C 132, 21.5.2010, p. 1).

9

(10)  Regulation (EU) No 996/2010 of the European Parliament and of the Council of 20 October 2010 on the investigation and prevention of accidents and incidents in civil aviation and repealing Directive 94/56/EC Text with EEA relevance (OJ L 295, 12.11.2010, p. 35).

10

(11)  That is, making sure that individuals are not identifiable taking into account all the means likely reasonably to be used either by the controller or by any other person.

11

(12)  Point 7 of Annex IV.

12

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V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 7.12.2013 | EN | Official Journal of the European Union | C 358/22 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/22

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Prior notification of a concentration

(Case COMP/M.6927 — Goldman Sachs/TPG Lundy/Barclays/Intertain)

Candidate case for simplified procedure

(Text with EEA relevance)

2013/C 358/12

| 1. | On 29 November 2013, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Goldman Sachs Group, Inc. (‘Goldman Sachs’), TPG LundyCO, L.P. (‘TPG’) and Barclays PLC (‘Barclays’) acquire, within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Intertain Limited (‘Intertain’) by way of purchase of shares. |
| --- | --- |

1.

On 29 November 2013, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Goldman Sachs Group, Inc. (‘Goldman Sachs’), TPG LundyCO, L.P. (‘TPG’) and Barclays PLC (‘Barclays’) acquire, within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Intertain Limited (‘Intertain’) by way of purchase of shares.

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






  — | Goldman Sachs is a global investment banking, securities and investment management firm that provides a wide range of services worldwide to a diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

Goldman Sachs is a global investment banking, securities and investment management firm that provides a wide range of services worldwide to a diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals,

| — | TPG is an investment vehicle belonging to the TPG Group, a global private investment firm that manages a family of funds that invest in a variety of companies through acquisitions and corporate restructurings, |
| --- | --- |

—

TPG is an investment vehicle belonging to the TPG Group, a global private investment firm that manages a family of funds that invest in a variety of companies through acquisitions and corporate restructurings,

| — | Barclays is the operating company of the Barclays Group, that is a global financial services provider engaged in personal banking, credit cards, corporate and investment banking, and wealth and investment management services, |
| --- | --- |

—

Barclays is the operating company of the Barclays Group, that is a global financial services provider engaged in personal banking, credit cards, corporate and investment banking, and wealth and investment management services,

| — | Intertain is an English limited company that operates bars and comedy venues in the United Kingdom. |
| --- | --- |

—

Intertain is an English limited company that operates bars and comedy venues in the United Kingdom.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope the EC Merger Regulation. However, the final decision on this point is reserved.Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope the EC Merger Regulation. However, the final decision on this point is reserved.Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.6927 — Goldman Sachs/TPG Lundy/Barclays/Intertain, to the following address:





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

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.6927 — Goldman Sachs/TPG Lundy/Barclays/Intertain, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

(2)  OJ C 56, 5.3.2005, p. 32 (‘Notice on a simplified procedure’).

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| 7.12.2013 | EN | Official Journal of the European Union | C 358/24 |
| --- | --- | --- | --- |

7.12.2013

EN

Official Journal of the European Union

C 358/24

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Prior notification of a concentration

(Case COMP/M.6817 — Allianz/Axa/Covéa/Generali/CSCA/Netproassur)

Candidate case for simplified procedure

(Text with EEA relevance)

2013/C 358/13

| 1. | On 2 December 2013, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Allianz IARD SA (‘Allianz’, France) belonging to the Allianz Group (Germany), Axa France IARD SA (‘Axa’, France) belonging to the Axa Group (France), Covéa Risk SA (‘Covéa’, France) belonging to the Covéa Group (France), Generali France Assurances SA (‘Generali’, France) belonging to the Assicurazioni Generali Group (Italy) and Chambre Syndicale des Courtiers d'Assurances (‘CSCA’, France) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Netproassur SASU (‘Netproassur’, France) by way of purchase of shares in a newly created company constituting a joint venture. |
| --- | --- |

1.

On 2 December 2013, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Allianz IARD SA (‘Allianz’, France) belonging to the Allianz Group (Germany), Axa France IARD SA (‘Axa’, France) belonging to the Axa Group (France), Covéa Risk SA (‘Covéa’, France) belonging to the Covéa Group (France), Generali France Assurances SA (‘Generali’, France) belonging to the Assicurazioni Generali Group (Italy) and Chambre Syndicale des Courtiers d'Assurances (‘CSCA’, France) acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Netproassur SASU (‘Netproassur’, France) by way of purchase of shares in a newly created company constituting a joint venture.

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






  — | Allianz: insurance company (selling insurance products covering property and liability (fire, motor vehicle liability and damage to property) in France), |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

Allianz: insurance company (selling insurance products covering property and liability (fire, motor vehicle liability and damage to property) in France),

| — | Axa: insurance company (selling insurance products for fire, motor vehicle liability and damage to property in France), |
| --- | --- |

—

Axa: insurance company (selling insurance products for fire, motor vehicle liability and damage to property in France),

| — | Covéa: insurance company (selling insurance products for fire, motor vehicle liability and damage to property in France), |
| --- | --- |

—

Covéa: insurance company (selling insurance products for fire, motor vehicle liability and damage to property in France),

| — | Generali: insurance company (selling products for life insurance and damage to property in France), |
| --- | --- |

—

Generali: insurance company (selling products for life insurance and damage to property in France),

| — | CSCA: French insurance brokerage employers' organisation, set up as a trade union confederation, |
| --- | --- |

—

CSCA: French insurance brokerage employers' organisation, set up as a trade union confederation,

| — | Netproassur: development, implementation and operation of information and communication technology projects relating to insurance and reinsurance brokerage. |
| --- | --- |

—

Netproassur: development, implementation and operation of information and communication technology projects relating to insurance and reinsurance brokerage.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the EC Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the EC Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the EC Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the EC Merger Regulation (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than ten days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.6817 — Allianz/Axa/Covéa/Generali/CSCA/Netproassur, to the following address:





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

4.

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

Observations must reach the Commission not later than ten days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.6817 — Allianz/Axa/Covéa/Generali/CSCA/Netproassur, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

(2)  OJ C 56, 5.3.2005, p. 32 (‘Notice on a simplified procedure’).

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