# Official Journal C 324/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 324 |
| | |
| English edition | Information and Notices | Volume 6412 August 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 324

English edition

Information and Notices

Volume 6412 August 2021

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| Contents | page |
| --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 324/01 | Non-opposition to a notified concentration (Case M.10346 — ICG/Circet) (
  1
  ) | 1 |
| 2021/C 324/02 | Non-opposition to a notified concentration (Case M.10337 — BC Partners/Vista Equity Partners/EAB Global) (
  1
  ) | 2 |
| 2021/C 324/03 | Non-opposition to a notified concentration (Case M.10322 — TPG/Francisco Partners/Boomi) (
  1
  ) | 3 |

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 324/01

Non-opposition to a notified concentration (Case M.10346 — ICG/Circet) (
  1
  )

1

1

2021/C 324/02

Non-opposition to a notified concentration (Case M.10337 — BC Partners/Vista Equity Partners/EAB Global) (
  1
  )

1

2

2021/C 324/03

Non-opposition to a notified concentration (Case M.10322 — TPG/Francisco Partners/Boomi) (
  1
  )

1

3

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 324/04 | Euro exchange rates — 11 August 2021 | 4 |
| 2021/C 324/05 | Commission Decision of 11 August 2021 on setting up the Commission expert group on statistics on plastic packaging waste | 5 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | EFTA Surveillance Authority |
| 2021/C 324/06 | State aid – Decision to raise no objections | 10 |
| 2021/C 324/07 | State aid – Decision to raise no objections | 11 |
| | Standing Committee of the EFTA States |
| 2021/C 324/08 | Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 44(5) of Regulation (EU) 528/2012 in the second half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee | 12 |
| 2021/C 324/09 | Dangerous substances - List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) in the second half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee | 14 |
| 2021/C 324/10 | Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee | 16 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 324/04

Euro exchange rates — 11 August 2021

4

2021/C 324/05

Commission Decision of 11 August 2021 on setting up the Commission expert group on statistics on plastic packaging waste

5

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

2021/C 324/06

State aid – Decision to raise no objections

10

2021/C 324/07

State aid – Decision to raise no objections

11

Standing Committee of the EFTA States

2021/C 324/08

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 44(5) of Regulation (EU) 528/2012 in the second half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee

12

2021/C 324/09

Dangerous substances - List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) in the second half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee

14

2021/C 324/10

Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee

16

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| | V   Announcements |
| --- | --- |
| | COURT PROCEEDINGS |
| | EFTA Court |
| 2021/C 324/11 | Judgment of the Court of 21 April 2021 in Case E-2/20 – The Norwegian Government, represented by the Immigration Appeals Board (Utlendingsnemnda – UNE) v L
  (Directive 2004/38/EC – Freedom of movement and residence – Expulsion – Protection against expulsion – Genuine, present and sufficiently serious threat – Imperative grounds of public security – Exclusion orders – Applications for lifting of exclusion orders –Material change – Necessity – Proportionality – Fundamental rights – Right to family life) | 29 |
| 2021/C 324/12 | Judgment of the Court of 5 May 2021 in Case E-8/20 – Criminal proceedings against N
  (Freedom to receive services – Freedom of movement for workers – Regulation (EEC) No 1408/71 – Regulation (EC) No 883/2004 – Retention of social security benefits in another EEA State – Sickness benefit – Stay – Restriction of a fundamental freedom – Justification) | 31 |
| | OTHER ACTS |
| | European Commission |
| 2021/C 324/13 | Publication of a communication of approval of a standard amendment to a product specification for a name in the wine sector referred to in Article 17(2) and (3) of Commission Delegated Regulation (EU) 2019/33 | 33 |

V   Announcements

COURT PROCEEDINGS

EFTA Court

2021/C 324/11

Judgment of the Court of 21 April 2021 in Case E-2/20 – The Norwegian Government, represented by the Immigration Appeals Board (Utlendingsnemnda – UNE) v L
  (Directive 2004/38/EC – Freedom of movement and residence – Expulsion – Protection against expulsion – Genuine, present and sufficiently serious threat – Imperative grounds of public security – Exclusion orders – Applications for lifting of exclusion orders –Material change – Necessity – Proportionality – Fundamental rights – Right to family life)

Utlendingsnemnda – UNE

(Directive 2004/38/EC – Freedom of movement and residence – Expulsion – Protection against expulsion – Genuine, present and sufficiently serious threat – Imperative grounds of public security – Exclusion orders – Applications for lifting of exclusion orders –Material change – Necessity – Proportionality – Fundamental rights – Right to family life)

29

2021/C 324/12

Judgment of the Court of 5 May 2021 in Case E-8/20 – Criminal proceedings against N
  (Freedom to receive services – Freedom of movement for workers – Regulation (EEC) No 1408/71 – Regulation (EC) No 883/2004 – Retention of social security benefits in another EEA State – Sickness benefit – Stay – Restriction of a fundamental freedom – Justification)

(Freedom to receive services – Freedom of movement for workers – Regulation (EEC) No 1408/71 – Regulation (EC) No 883/2004 – Retention of social security benefits in another EEA State – Sickness benefit – Stay – Restriction of a fundamental freedom – Justification)

31

OTHER ACTS

European Commission

2021/C 324/13

Publication of a communication of approval of a standard amendment to a product specification for a name in the wine sector referred to in Article 17(2) and (3) of Commission Delegated Regulation (EU) 2019/33

33

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

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(1)   Text with EEA relevance.

1

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

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 12.8.2021 | EN | Official Journal of the European Union | C 324/1 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/1

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Non-opposition to a notified concentration

(Case M.10346 — ICG/Circet)

(Text with EEA relevance)

(2021/C 324/01)

On 26 July 2021, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | in the merger section of the Competition 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/homepage.html?locale=en) under document number 32021M10346. EUR-Lex is the online access to European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10346. EUR-Lex is the online access to European law.

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

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| 12.8.2021 | EN | Official Journal of the European Union | C 324/2 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/2

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Non-opposition to a notified concentration

(Case M.10337 — BC Partners/Vista Equity Partners/EAB Global)

(Text with EEA relevance)

(2021/C 324/02)

On 4 August 2021, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | in the merger section of the Competition 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/homepage.html?locale=en) under document number 32021M10337. EUR-Lex is the online access to European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10337. EUR-Lex is the online access to European law.

---

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

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| 12.8.2021 | EN | Official Journal of the European Union | C 324/3 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/3

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Non-opposition to a notified concentration

(Case M.10322 — TPG/Francisco Partners/Boomi)

(Text with EEA relevance)

(2021/C 324/03)

On 16 July 2021, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | in the merger section of the Competition 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/homepage.html?locale=en) under document number 32021M10322. EUR-Lex is the online access to European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10322. EUR-Lex is the online access to European law.

---

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

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 12.8.2021 | EN | Official Journal of the European Union | C 324/4 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/4

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Euro exchange rates (1)

11 August 2021

(2021/C 324/04)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,1718 |
| JPY | Japanese yen | 129,68 |
| DKK | Danish krone | 7,4373 |
| GBP | Pound sterling | 0,84698 |
| SEK | Swedish krona | 10,2305 |
| CHF | Swiss franc | 1,0818 |
| ISK | Iceland króna | 148,00 |
| NOK | Norwegian krone | 10,4548 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,405 |
| HUF | Hungarian forint | 354,84 |
| PLN | Polish zloty | 4,5858 |
| RON | Romanian leu | 4,9163 |
| TRY | Turkish lira | 10,1467 |
| AUD | Australian dollar | 1,5958 |
| CAD | Canadian dollar | 1,4677 |
| HKD | Hong Kong dollar | 9,1187 |
| NZD | New Zealand dollar | 1,6704 |
| SGD | Singapore dollar | 1,5924 |
| KRW | South Korean won | 1 357,41 |
| ZAR | South African rand | 17,3326 |
| CNY | Chinese yuan renminbi | 7,5996 |
| HRK | Croatian kuna | 7,4955 |
| IDR | Indonesian rupiah | 16 881,52 |
| MYR | Malaysian ringgit | 4,9684 |
| PHP | Philippine peso | 59,126 |
| RUB | Russian rouble | 86,8412 |
| THB | Thai baht | 39,062 |
| BRL | Brazilian real | 6,1113 |
| MXN | Mexican peso | 23,5291 |
| INR | Indian rupee | 87,1605 |

Currency

Exchange rate

USD

US dollar

1,1718

JPY

Japanese yen

129,68

DKK

Danish krone

7,4373

GBP

Pound sterling

0,84698

SEK

Swedish krona

10,2305

CHF

Swiss franc

1,0818

ISK

Iceland króna

148,00

NOK

Norwegian krone

10,4548

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,405

HUF

Hungarian forint

354,84

PLN

Polish zloty

4,5858

RON

Romanian leu

4,9163

TRY

Turkish lira

10,1467

AUD

Australian dollar

1,5958

CAD

Canadian dollar

1,4677

HKD

Hong Kong dollar

9,1187

NZD

New Zealand dollar

1,6704

SGD

Singapore dollar

1,5924

KRW

South Korean won

1 357,41

ZAR

South African rand

17,3326

CNY

Chinese yuan renminbi

7,5996

HRK

Croatian kuna

7,4955

IDR

Indonesian rupiah

16 881,52

MYR

Malaysian ringgit

4,9684

PHP

Philippine peso

59,126

RUB

Russian rouble

86,8412

THB

Thai baht

39,062

BRL

Brazilian real

6,1113

MXN

Mexican peso

23,5291

INR

Indian rupee

87,1605

---

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

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| 12.8.2021 | EN | Official Journal of the European Union | C 324/5 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/5

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COMMISSION DECISION

of 11 August 2021

on setting up the Commission expert group on statistics on plastic packaging waste

(2021/C 324/05)

THE EUROPEAN COMMISSION,

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

Whereas:

| (1) | Pursuant to Article 338 of the Treaty on the Functioning of the European Union, the European Parliament and the Council adopt measures for the production of statistics where necessary for the performance of the activities of the Union. |
| --- | --- |

(1)

Pursuant to Article 338 of the Treaty on the Functioning of the European Union, the European Parliament and the Council adopt measures for the production of statistics where necessary for the performance of the activities of the Union.

| (2) | Pursuant to Article 13 of Council Regulation (EU, Euratom) 2021/770 (1), the Commission must establish a formal expert group, composed of representatives of all Member States and chaired by a representative of the Commission, to advise the Commission and to express its views on the comparability, reliability and exhaustiveness of the statistics on plastic packaging waste generated and recycled, to advise the Commission on preparing measures to make the data more comparable and more reliable and to issue annual opinions on the appropriateness of the plastic packaging waste data submitted by the Member States for the purposes of the own resource based on non-recycled plastic packaging waste. |
| --- | --- |

(2)

Pursuant to Article 13 of Council Regulation (EU, Euratom) 2021/770 (1), the Commission must establish a formal expert group, composed of representatives of all Member States and chaired by a representative of the Commission, to advise the Commission and to express its views on the comparability, reliability and exhaustiveness of the statistics on plastic packaging waste generated and recycled, to advise the Commission on preparing measures to make the data more comparable and more reliable and to issue annual opinions on the appropriateness of the plastic packaging waste data submitted by the Member States for the purposes of the own resource based on non-recycled plastic packaging waste.

| (3) | It is therefore necessary to set up a group of experts (the ‘SPPW expert group’) in the field of statistics on plastic packaging waste and to define its tasks, its structure and its operation, in compliance with Commission Decision C(2016) 3301 establishing horizontal rules on the creation and operation of Commission expert groups. |
| --- | --- |

(3)

It is therefore necessary to set up a group of experts (the ‘SPPW expert group’) in the field of statistics on plastic packaging waste and to define its tasks, its structure and its operation, in compliance with Commission Decision C(2016) 3301 establishing horizontal rules on the creation and operation of Commission expert groups.

| (4) | The SPPW expert group should each year express an opinion on the appropriateness of the plastic packaging waste data submitted annually by the Member States for use in the system of own resources of the European Union. |
| --- | --- |

(4)

The SPPW expert group should each year express an opinion on the appropriateness of the plastic packaging waste data submitted annually by the Member States for use in the system of own resources of the European Union.

| (5) | The SPPW expert group should be composed of experts in plastic packaging waste statistics from all Member States. |
| --- | --- |

(5)

The SPPW expert group should be composed of experts in plastic packaging waste statistics from all Member States.

| (6) | Rules on disclosure of information by members of the SPPW expert group should be laid down. |
| --- | --- |

(6)

Rules on disclosure of information by members of the SPPW expert group should be laid down.

| (7) | Personal data should be processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (2), |
| --- | --- |

(7)

Personal data should be processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (2),

HAS DECIDED AS FOLLOWS:

Article 1

Subject matter

The Commission expert group on statistics on plastic packaging waste, (‘the SPPW expert group’) is hereby set up.

Article 2

Tasks

The SPPW expert group’s tasks shall be as follows:

| (a) | to advise the Commission and to express its views with regard to the comparability, reliability and exhaustiveness of the statistics on plastic packaging waste generated and recycled; |
| --- | --- |

(a)

to advise the Commission and to express its views with regard to the comparability, reliability and exhaustiveness of the statistics on plastic packaging waste generated and recycled;

| (b) | to advise the Commission on preparing measures to make the statistics more comparable and more reliable; |
| --- | --- |

(b)

to advise the Commission on preparing measures to make the statistics more comparable and more reliable;

| (c) | to examine, on an annual basis, the data submitted in accordance with Article 5(5) of Regulation (EU, Euratom) 2021/770; |
| --- | --- |

(c)

to examine, on an annual basis, the data submitted in accordance with Article 5(5) of Regulation (EU, Euratom) 2021/770;

| (d) | to issue annual opinions on the appropriateness of the plastic packaging waste data submitted by the Member States for the purposes of the own resource based on non-recycled plastic packaging waste; |
| --- | --- |

(d)

to issue annual opinions on the appropriateness of the plastic packaging waste data submitted by the Member States for the purposes of the own resource based on non-recycled plastic packaging waste;

| (e) | to examine issues regarding the implementation of Regulation (EU, Euratom) 2021/770; |
| --- | --- |

(e)

to examine issues regarding the implementation of Regulation (EU, Euratom) 2021/770;

| (f) | to assist the Commission in preparing legislative proposals and policy initiatives on the harmonisation of the statistics on plastic packaging waste; |
| --- | --- |

(f)

to assist the Commission in preparing legislative proposals and policy initiatives on the harmonisation of the statistics on plastic packaging waste;

| (g) | to assist the Commission in the early preparation of implementing acts to be adopted pursuant to Regulation (EU, Euratom) 2021/770, before submission to the committee in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council; |
| --- | --- |

(g)

to assist the Commission in the early preparation of implementing acts to be adopted pursuant to Regulation (EU, Euratom) 2021/770, before submission to the committee in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council;

| (h) | to facilitate the exchange of experience and good practice in the field of statistics on plastic packaging waste; |
| --- | --- |

(h)

to facilitate the exchange of experience and good practice in the field of statistics on plastic packaging waste;

| (i) | to advise the Commission on questions related to revision policies of statistics on plastic packaging waste. |
| --- | --- |

(i)

to advise the Commission on questions related to revision policies of statistics on plastic packaging waste.

Article 3

Consultation

The Commission may consult the SPPW expert group on any matter relating to plastic packaging waste data.

Article 4

Membership

(1)   Members shall be the Member States’ authorities responsible for reporting the data according to Article 12 of European Parliament and Council Directive 94/62/EC (3).

(2)   Member States shall appoint their representatives and shall ensure that their representatives provide a high level of expertise in compiling statistics on plastic packaging waste.

Article 5

Chair

The SPPW expert group shall be chaired by a representative of the Commission (Eurostat).

Article 6

Operation

(1)   The SPPW expert group shall act at the request of the Commission (Eurostat), in compliance with the Commission’s horizontal rules on expert groups (4) (‘the horizontal rules’) (5).

(2)   Meetings of the group shall, in principle, be held on Commission premises.

(3)   The Commission (Eurostat) shall provide secretarial services.

(4)   Commission officials from other departments with an interest in the proceedings may attend meetings of the group and its sub-groups.

(5)   In agreement with the Commission (Eurostat), the group may, by simple majority of its members, decide that deliberations shall be public.

(6)   Minutes on the discussion on each point on the agenda and on the opinions delivered by the SPPW expert group shall be meaningful and complete. Minutes shall be drafted by the secretariat under the responsibility of the Chair.

(7)   The SPPW expert group shall adopt its opinions, recommendations or reports where possible by consensus.

(8)   In the event of a vote, the outcome of the vote shall be decided by simple majority of the members. The members who voted against or abstained shall have the right to have a document summarising the reasons for their position annexed to the opinions, recommendations or reports.

Article 7

Sub-groups

The Commission (Eurostat) may set up sub-groups for the purpose of examining specific questions on the basis of terms of reference defined by the Commission (Eurostat). Sub-groups shall operate in compliance with the horizontal rules and shall report to the group. They shall be dissolved as soon as their mandate is fulfilled.

Article 8

Invited experts

The Commission (Eurostat) may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the SPPW expert group or its sub-groups on an ad hoc basis.

Article 9

Observers

(1)   Organisations or public entities other than Member States’ authorities may be granted an observer status, in compliance with the horizontal rules, by direct invitation.

(2)   Organisations or public entities appointed as observers shall nominate their representatives.

(3)   Observers and their representatives may be permitted by the Chair to take part in the discussions of the SPPW expert group and provide expertise. However, they shall not have voting rights and shall not participate in the formulation of recommendations or advice of the SPPW expert group.

Article 10

Rules of procedure

On a proposal by the Commission (Eurostat) and with its agreement, the SPPW expert group shall adopt its rules of procedure by simple majority of its members, on the basis of the standard rules of procedure for expert groups, in compliance with the horizontal rules.

Article 11

Professional secrecy and handling of classified information

(1)   The members of the SPPW expert group and their representatives, as well as invited experts and observers, are subject to the obligation of professional secrecy, which by virtue of the Treaties and the rules implementing them applies to all members of the institutions and their staff, as well as to the Commission’s rules on security regarding the protection of Union classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 (6) and (EU, Euratom) 2015/444 (7). Should they fail to respect those obligations, the Commission may take all appropriate measures.

(2)   The members of the SPPW expert group and their representatives, as well as invited experts and observers shall respect the statistical confidentiality, laid down in Regulation (EC) No 223/2009, and in particular in Article 20 (Protection of confidential data) thereof.

Article 12

Transparency

(1)   The SPPW expert group and its sub-groups shall be registered in the Register of Commission expert groups and other similar entities (‘the Register of expert groups’). The name of the Member States’ authorities and the names of observers shall be published on the Register of expert groups.

(2)   All relevant documents, including the agendas, the minutes and the participants’ submissions, shall be made available after the meetings via a link from the Register of expert groups to a dedicated website. Access to dedicated websites shall not be subject to user registration or any other restriction. The agenda shall be published in due time ahead of the meeting, followed by timely publication of minutes. Exceptions to publication shall only be foreseen where it is deemed that disclosure of a document would undermine the protection of a public or private interest as defined in Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (8).

Article 13

Meeting expenses

(1)   Participants in the activities of the SPPW expert group and its sub-groups shall not be remunerated for their services.

(2)   Travel and subsistence expenses incurred by participants in the activities of the SPPW expert group and its sub-groups shall be reimbursed by the Commission in accordance with the provisions in force within the Commission and within the limits of the available appropriations allocated to the Commission departments under the annual procedure for the allocation of resources.

Done at Brussels, 11 August 2021.

For the Commission

Paolo GENTILONI

Member of the Commission

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(1)  Council Regulation (EU, Euratom) 2021/770 of 30 April 2021 on the calculation of the own resource based on plastic packaging waste that is not recycled, on the methods and procedure for making available that own resource, on the measures to meet cash requirements, and on certain aspects of the own resource based on gross national income (OJ L 165, 11.5.2021, p. 15).

1

(2)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

2

(3)  European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10).

3

(4)  Commission Decision C (2016) 3301 of 30 May 2016 establishing horizontal rules on the creation and operation of Commission expert groups.

4

(5)  See Article 13.1 of the horizontal rules.

5

(6)  Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).

6

(7)  Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).

7

(8)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). Exceptions intended to protect public security, military affairs, international relations, financial, monetary or economic policy, privacy and integrity of the individual, commercial interests, court proceedings and legal advice, inspections/investigations/audits and the institution’s decision-making process.

8

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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

| 12.8.2021 | EN | Official Journal of the European Union | C 324/10 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/10

---

State aid – Decision to raise no objections

(2021/C 324/06)

The EFTA Surveillance Authority raises no objections to the following state aid measure:

| Date of adoption of the decision | 29 April 2021 |
| --- | --- |
| Case No | 86666 |
| Decision No | 034/21/COL |
| EFTA State | Norway |
| Title (and/or name of the beneficiary) | State aid to support dedicated alternative fuels infrastructure 2021-2025 |
| Legal basis | Enova Programmes |
| Type of measure | Scheme |
| Objective | Environmental |
| Form of aid | Grants |
| Budget | NOK 200 million |
| Intensity | 40 % for large enterprises, 50 % for medium-sized enterprises and 60 % for small enterprises |
| Duration | Until 31 December 2025 |
| Economic sectors | Open to all sectors |
| Name and address of the granting authority | Enova SF |
| Brattørkaia 17A |
| N-7010 Trondheim |
| NORWAY |

Date of adoption of the decision

29 April 2021

Case No

86666

Decision No

034/21/COL

EFTA State

Norway

Title (and/or name of the beneficiary)

State aid to support dedicated alternative fuels infrastructure 2021-2025

Legal basis

Enova Programmes

Type of measure

Scheme

Objective

Environmental

Form of aid

Grants

Budget

NOK 200 million

Intensity

40 % for large enterprises, 50 % for medium-sized enterprises and 60 % for small enterprises

Duration

Until 31 December 2025

Economic sectors

Open to all sectors

Name and address of the granting authority

Enova SF

Brattørkaia 17A

N-7010 Trondheim

NORWAY

The authentic text of the decision, from which all confidential information has been removed, can be found on the EFTA Surveillance Authority’s website: http://www.eftasurv.int/state-aid/state-aid-register/decisions/

---

| 12.8.2021 | EN | Official Journal of the European Union | C 324/11 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/11

---

State aid – Decision to raise no objections

(2021/C 324/07)

The EFTA Surveillance Authority raises no objections to the following state aid measure:

| Date of adoption of the decision | 6 May 2021 |
| --- | --- |
| Case No | 86794 |
| Decision No | 036/21/COL |
| EFTA State | Norway |
| Title (and/or name of the beneficiary) | COVID-19 scheme for producers of cultural films |
| Legal basis | Regulation on aid to audio-visual production |
| Type of measure | Scheme |
| Objective | To ensure that the disruptions caused by the COVID-19 outbreak do not undermine the viability of producers of cultural films and the future production of cultural film. |
| Form of aid | Direct grant |
| Budget | NOK 10 million |
| Intensity | A grant of up to 100% of the estimated loss of income from box-office revenue from 13 March to 30 September 2020. |
| Duration | 6 May – 31 December 2021 |
| Economic sectors | Audiovisual production |
| Name and address of the granting authority | Norwegian Film Institute |
| P.O. Box 482 |
| N-0105 Oslo |
| NORWAY |

Date of adoption of the decision

6 May 2021

Case No

86794

Decision No

036/21/COL

EFTA State

Norway

Title (and/or name of the beneficiary)

COVID-19 scheme for producers of cultural films

Legal basis

Regulation on aid to audio-visual production

Type of measure

Scheme

Objective

To ensure that the disruptions caused by the COVID-19 outbreak do not undermine the viability of producers of cultural films and the future production of cultural film.

Form of aid

Direct grant

Budget

NOK 10 million

Intensity

A grant of up to 100% of the estimated loss of income from box-office revenue from 13 March to 30 September 2020.

Duration

6 May – 31 December 2021

Economic sectors

Audiovisual production

Name and address of the granting authority

Norwegian Film Institute

P.O. Box 482

N-0105 Oslo

NORWAY

The authentic text of the decision, from which all confidential information has been removed, can be found on the EFTA Surveillance Authority’s website: http://www.eftasurv.int/state-aid/state-aid-register/decisions/

---

Standing Committee of the EFTA States

| 12.8.2021 | EN | Official Journal of the European Union | C 324/12 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/12

---

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 44(5) of Regulation (EU) 528/2012 in the second half of 2020

(2021/C 324/08)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 225/2013 of 13 December 2013, the EEA Joint Committee is invited to note the following lists concerning authorisation decisions adopted on the basis of Article 44(5) of Regulation (EU) No 528/2012 for the period 1 July – 31 December 2020, at their meeting on 19 March 2021.

---

ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 44(5) of Regulation (EU) No 528/2012 have been taken in the EEA EFTA States during the period 1 July – 31 December 2020:

| Biocidal Product Name | Union authorisation decisions under Article 44(5) of Regulation (EU) No 528/2012 | Country | Date of decision |
| --- | --- | --- | --- |
| ClearKlens product based on IPA | 32020R1147 | Iceland | 20.11.2020 |
| ClearKlens product based on IPA | 32020R1147 | Liechtenstein | 16.11.2020 |
| ClearKlens product based on IPA | 32020R1147 | Norway | 16.11.2020 |
| HYPRED’s octanoic acid based products | 32020R0579 | Iceland | 13.8.2020 |
| HYPRED’s octanoic acid based products | 32020R0579 | Liechtenstein | 20.7.2020 |
| HYPRED’s octanoic acid based products | 32020R0579 | Norway | 19.8.2020 |
| INSECTICIDES FOR HOME USE’ | 32020R0704 | Iceland | 20.11.2020 |
| INSECTICIDES FOR HOME USE’ | 32020R0704 | Liechtenstein | 22.9.2020 |
| INSECTICIDES FOR HOME USE’ | 32020R0704 | Norway | 12.10.2020 |
| Iodine based products – CID LINES NV | 32020R1187 | Iceland | 17.12.2020 |
| Iodine based products – CID LINES NV | 32020R1187 | Liechtenstein | 30.11.2020 |
| Iodine based products – CID LINES NV | 32020R1187 | Norway | 8.12.2020 |
| SOPURCLEAN | 32020R0580 | Iceland | 13.8.2020 |
| SOPURCLEAN | 32020R0580 | Liechtenstein | 21.7.2020 |
| SOPURCLEAN | 32020R0580 | Norway | 18.8.2020 |

Biocidal Product Name

Union authorisation decisions under Article 44(5) of Regulation (EU) No 528/2012

Country

Date of decision

ClearKlens product based on IPA

32020R1147

Iceland

20.11.2020

ClearKlens product based on IPA

32020R1147

Liechtenstein

16.11.2020

ClearKlens product based on IPA

32020R1147

Norway

16.11.2020

HYPRED’s octanoic acid based products

32020R0579

Iceland

13.8.2020

HYPRED’s octanoic acid based products

32020R0579

Liechtenstein

20.7.2020

HYPRED’s octanoic acid based products

32020R0579

Norway

19.8.2020

INSECTICIDES FOR HOME USE’

32020R0704

Iceland

20.11.2020

INSECTICIDES FOR HOME USE’

32020R0704

Liechtenstein

22.9.2020

INSECTICIDES FOR HOME USE’

32020R0704

Norway

12.10.2020

Iodine based products – CID LINES NV

32020R1187

Iceland

17.12.2020

Iodine based products – CID LINES NV

32020R1187

Liechtenstein

30.11.2020

Iodine based products – CID LINES NV

32020R1187

Norway

8.12.2020

SOPURCLEAN

32020R0580

Iceland

13.8.2020

SOPURCLEAN

32020R0580

Liechtenstein

21.7.2020

SOPURCLEAN

32020R0580

Norway

18.8.2020

---

| 12.8.2021 | EN | Official Journal of the European Union | C 324/14 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/14

---

Dangerous substances - List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) in the second half of 2020

(2021/C 324/09)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 25/2008 of 14 March 2008, the EEA Joint Committee is invited to note the following lists concerning authorisation decisions adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH) for the period 1 July – 31 December 2020, at their meeting on 19 March 2021.

---

ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) have been taken in the EEA EFTA States during the period 1 July – 31 December 2020:

| Substance name | Commission decision under Article 64(8) of Regulation (EC) No 1907/2006 | Country | Date of decision |
| --- | --- | --- | --- |
| Chromium trioxide | C(2020) 7104 | Iceland | 20.11.2020 |
| Chromium trioxide | C(2020) 7104 | Norway | 10.11.2020 |
| Sodium dichromate | C(2020) 5826 | Iceland | 21.9.2020 |
| Sodium dichromate | C(2020) 5826 | Liechtenstein | 22.9.2020 |
| Sodium dichromate | C(2020) 5826 | Norway | 25.9.2020 |
| Sodium dichromate | C(2020) 6518 | Iceland | 14.10.2020 |
| Sodium dichromate | C(2020) 6518 | Liechtenstein | 14.10.2020 |
| Sodium dichromate | C(2020) 6518 | Norway | 29.10.2020 |
| Strontium chromate | C(2020) 6231 | Iceland | 30.9.2020 |
| Strontium chromate | C(2020) 6231 | Liechtenstein | 6.10.2020 |
| Strontium chromate | C(2020) 6231 | Norway | 25.9.2020 |

Substance name

Commission decision under Article 64(8) of Regulation (EC) No 1907/2006

Country

Date of decision

Chromium trioxide

C(2020) 7104

Iceland

20.11.2020

Chromium trioxide

C(2020) 7104

Norway

10.11.2020

Sodium dichromate

C(2020) 5826

Iceland

21.9.2020

Sodium dichromate

C(2020) 5826

Liechtenstein

22.9.2020

Sodium dichromate

C(2020) 5826

Norway

25.9.2020

Sodium dichromate

C(2020) 6518

Iceland

14.10.2020

Sodium dichromate

C(2020) 6518

Liechtenstein

14.10.2020

Sodium dichromate

C(2020) 6518

Norway

29.10.2020

Strontium chromate

C(2020) 6231

Iceland

30.9.2020

Strontium chromate

C(2020) 6231

Liechtenstein

6.10.2020

Strontium chromate

C(2020) 6231

Norway

25.9.2020

---

| 12.8.2021 | EN | Official Journal of the European Union | C 324/16 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/16

---

Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2020

(2021/C 324/10)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July – 31 December 2020, at their meeting on 19 March 2021:

| Annex I | List of new marketing authorisations |
| --- | --- |

Annex I

| Annex II | List of renewed marketing authorisations |
| --- | --- |

Annex II

| Annex III | List of extended marketing authorisations |
| --- | --- |

Annex III

| Annex IV | List of withdrawn marketing authorisations |
| --- | --- |

Annex IV

| Annex V | List of suspended marketing authorisations |
| --- | --- |

Annex V

---

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July – 31 December 2020:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/20/1476 | Adakveo | Iceland | 6.11.2020 |
| EU/1/20/1476 | Adakveo | Norway | 5.11.2020 |
| EU/1/20/1458 | Apixaban Accord | Iceland | 10.8.2020 |
| EU/1/20/1458 | Apixaban Accord | Liechtenstein | 31.8.2020 |
| EU/1/20/1458 | Apixaban Accord | Norway | 10.8.2020 |
| EU/1/20/1469 | Arikayce liposomal | Norway | 2.11.2020 |
| EU/1/20/1469 | Arikayce liposomal | Iceland | 5.11.2020 |
| EU/1/20/1475 | Arsenic trioxide medac | Iceland | 14.10.2020 |
| EU/1/20/1475 | Arsenic trioxide medac | Norway | 29.9.2020 |
| EU/1/20/1454 | Aybintio | Iceland | 25.8.2020 |
| EU/120/1454 | Aybintio | Liechtenstein | 31.8.2020 |
| EU/1/20/1454 | Aybintio | Norway | 25.8.2020 |
| EU/1/20/1473 | AYVAKYT | Iceland | 14.10.2020 |
| EU/1/20/1473 | Ayvakyt | Norway | 29.9.2020 |
| EU/1/17/1214 | Bavencio | Liechtenstein | 31.8.2020 |
| EU/1/20/1474 | Blenrep | Iceland | 14.9.2020 |
| EU/1/20/1474 | Blenrep | Liechtenstein | 31.8.2020 |
| EU/1/20/1474 | Blenrep | Norway | 2.9.2020 |
| EU/1/19/1403 | Budesonid/Formoterol Teva Pharma B.V. | Liechtenstein | 31.8.2020 |
| EU/1/20/1448 | Cabazitaxel Accord | Iceland | 3.9.2020 |
| EU/1/20/1448 | Cabazitaxel Accord | Norway | 28.10.2020 |
| EU/1/20/1479 | Calquence | Iceland | 10.11.2020 |
| EU/1/20/1479 | Calquence | Norway | 11.11.2020 |
| EU/2/20/264 | Circomax Myco | Norway | 16.12.2020 |
| EU/1/20/1528 | Comirnaty | Iceland | 21.12.2020 |
| EU/1/20/1528 | Comirnaty | Norway | 21.12.2020 |
| EU/1/20/1451 | Daurismo | Iceland | 20.7.2020 |
| EU/1/20/1451 | Daurismo | Norway | 3.7.2020 |
| EU/1/20/1438 | Enerzair Breezhaler | Iceland | 21.7.2020 |
| EU/1/20/1438 | Enezair Breezhaler | Norway | 14.7.2020 |
| EU/2/20/262 | Enteroporc Coli AC | Norway | 16.12.2020 |
| EU/1/20/1472 | Equidacent | Iceland | 14.10.2020 |
| EU/1/20/1472 | Equidacent | Norway | 29.9.2020 |
| EU/1/20/1489 | Exparel liposomal | Iceland | 3.12.2020 |
| EU/1/20/1489 | Exparel liposomal | Norway | 24.11.2020 |
| EU/1/20/1477 | Fampridine Accord | Iceland | 15.10.2020 |
| EU/1/20/1477 | Fampridine Accord | Norway | 1.10.2020 |
| EU/1/20/1450 | Fingolimod Accord | Iceland | 20.7.2020 |
| EU/1/20/1450 | Fingolimod Accord | Norway | 13.7.2020 |
| EU/1/20/1465 | Gencebok | Iceland | 25.8.2020 |
| EU/1/20/1465 | Gencebok | Liechtenstein | 31.8.2020 |
| EU/1/20/1465 | Gencebok | Norway | 2.9.2020 |
| EU/1/20/1446 | Hepcludex | Iceland | 12.8.2020 |
| EU/1/20/1446 | Hepcludex | Liechtenstein | 31.8.2020 |
| EU/1/20/1446 | Hepcludex | Norway | 10.8.2020 |
| EU/1/20/1471 | Idefirix | Iceland | 2.9.2020 |
| EU/1/20/1471 | Idefirix | Liechtenstein | 31.8.2020 |
| EU/1/20/1471 | Idefirix | Norway | 8.9.2020 |
| EU/2/20/258 | Increxxa | Iceland | 21.9.2020 |
| EU/2/20/256 | Innovax-ND-ILT | Iceland | 16.10.2020 |
| EU/1/20/1447 | Insulin Aspart Sanofi | Iceland | 20.7.2020 |
| EU/1/20/144 | Insulin aspart Sanofi | Norway | 3.7.2020 |
| EU/1/20/1480 | Jyseleca | Iceland | 14.10.2020 |
| EU/1/20/1480 | Jyseleca | Norway | 30.9.2020 |
| EU/1/20/1468 | Kaftrio | Iceland | 25.8.2020 |
| EU/1/20/1468 | Kaftrio | Liechtenstein | 31.8.2020 |
| EU/1/20/1468 | Kaftrio | Norway | 3.9.2020 |
| EU/1/20/1494 | Leqvio | Norway | 15.12.2020 |
| EU/2/20/261 | Librela | Iceland | 13.11.2020 |
| EU/1/20/1462 | Livogiva | Iceland | 2.9.2020 |
| EU/1/20/1462 | Livogiva | Liechtenstein | 31.8.2020 |
| EU/1/20/1462 | Livogiva | Norway | 7.9.2020 |
| EU/1/20/1483 | MenQuadfi | Iceland | 2.12.2020 |
| EU/1/20/1483 | MenQuadfi | Norway | 30.11.2020 |
| EU/1/20/1470 | Methylthioninium chloride Cosmo | Iceland | 27.8.2020 |
| EU/1/20/1470 | Methylthioninium chloride Cosmo | Norway | 3.9.2020 |
| EU/2/20/259 | Mhyosphere PCV ID | Iceland | 14.10.2020 |
| EU/2/19/247 | Mirataz | Norway | 11.8.2020 |
| EU/1/20/1445 | Mvabea | Iceland | 21.7.2020 |
| EU/1/20/1445 | Mvabea | Norway | 13.7.2020 |
| EU/2/20/265 | Nobivac DP PLUS | Norway | 17.12.2020 |
| EU/1/20/1424 | Nustendi | Liechtenstein | 31.8.2020 |
| EU/1/20/1486 | Nyvepria | Iceland | 3.12.2020 |
| EU/1/20/1486 | Nyvepria | Norway | 24.11.2020 |
| EU/1/20/1485 | Obiltoxaximab SFL | Iceland | 8.12.2020 |
| EU/1/20/1485 | Obiltoxaximab SFL | Norway | 24.11.2020 |
| EU/2/20/260 | OvuGel | Iceland | 8.12.2020 |
| EU/1/20/1496 | Oxlumo | Iceland | 2.12.2020 |
| EU/1/20/1496 | Oxlumo | Norway | 24.11.2020 |
| EU/1/20/1487 | PHELINUN | Iceland | 3.12.2020 |
| EU/1/20/1487 | PHELINUN | Norway | 2.12.2020 |
| EU/1/20/1497 | Phesgo | Norway | 23.12.2020 |
| EU/1/20/1455 | Piqray | Iceland | 11.8.2020 |
| EU/1/20/1455 | Piqray | Liechtenstein | 31.8.2020 |
| EU/1/20/1455 | Piqray | Norway | 10.8.2020 |
| EU/1/20/1437 | Pretomanid FGK | Iceland | 12.8.2020 |
| EU/1/20/1437 | Pretomanid FGK | Liechtenstein | 31.8.2020 |
| EU/1/20/1437 | Pretomanid FGK | Norway | 10.8.2020 |
| EU/2/20/254 | Prevexxion RN | Iceland | 10.8.2020 |
| EU/2/20/254 | Prevexxion RN | Norway | 10.8.2020 |
| EU/2/20/255 | Prevexxion RN+HVT+IBD | Iceland | 27.7.2020 |
| EU/2/20/255 | Prevexxion RN+HVT+IBD | Liechtenstein | 31.8.2020 |
| EU/1/20/1463 | Qutavina | Iceland | 2.9.2020 |
| EU/1/20/1463 | Qutavina | Liechtenstein | 31.8.2020 |
| EU/1/20/1463 | Qutavina | Norway | 7.9.2020 |
| EU/1/20/1452 | Reblozyl | Iceland | 20.7.2020 |
| EU/1/20/1452 | Reblozyl | Norway | 3.7.2020 |
| EU/2/20/263 | Rexxolide | Norway | 16.12.2020 |
| EU/1/20/1488 | Rivaroxaban Accord | Iceland | 1.12.2020 |
| EU/1/20/1488 | Rivaroxaban Accord | Norway | 2.12.2020 |
| EU/1/20/1460 | Rozlytrek | Iceland | 12.8.2020 |
| EU/1/20/1460 | Rozlytrek | Norway | 10.8.2020 |
| EU/1/20/1484 | Supemtek | Iceland | 1.12.2020 |
| EU/1/20/1484 | Supemtek | Norway | 24.11.2020 |
| EU/1/20/1492 | Tecartus | Norway | 30.12.2020 |
| EU/1/20/1498 | TRIXEO AEROSPHERE | Norway | 16.12.2020 |
| EU/2/20/257 | Tulinovet | Iceland | 21.9.2020 |
| EU/2/20/257 | Tulinovet | Norway | 8.12.2020 |
| EU/1/20/1459 | Veklury | Iceland | 3.7.2020 |
| EU1/20/1459 | Veklury | Liechtenstein | 31.8.2020 |
| EU/1/20/1459 | Veklury | Norway | 3.7.2020 |
| EU/1/20/1481 | Vocabria | Norway | 30.12.2020 |
| EU/1/20/1457 | Xenleta | Iceland | 11.8.2020 |
| EU/1/20/1457 | Xenleta | Liechtenstein | 31.8.2020 |
| EU/1/20/1457 | Xenleta | Norway | 10.8.2020 |
| EU/1/20/1444 | Zabdeno | Iceland | 21.7.2020 |
| EU/1/20/1444 | Zabdeno | Liechtenstein | 31.8.2020 |
| EU/1/20/1444 | Zabdeno | Norway | 14.7.2020 |
| EU/1/20/1456 | Zercepac | Iceland | 11.8.2020 |
| EU/1/20/1456 | Zercepac | Liechtenstein | 31.8.2020 |
| EU/1/20/1456 | Zercepac | Norway | 10.8.2020 |
| EU/1/20/1440 | Zimbus Breezhaler | Iceland | 21.7.2020 |
| EU/1/20/1440 | Zimbus Breezhaler | Liechtenstein | 31.8.2020 |
| EU/1/20/1440 | Zimbus Breezhaler | Norway | 13.7.2020 |
| EU/1/20/1478 | ZYNRELEF | Iceland | 16.10.2020 |
| EU/1/20/1478 | Zynrelef | Norway | 1.10.2020 |

EU-Number

Product

Country

Date of authorisation

EU/1/20/1476

Adakveo

Iceland

6.11.2020

EU/1/20/1476

Adakveo

Norway

5.11.2020

EU/1/20/1458

Apixaban Accord

Iceland

10.8.2020

EU/1/20/1458

Apixaban Accord

Liechtenstein

31.8.2020

EU/1/20/1458

Apixaban Accord

Norway

10.8.2020

EU/1/20/1469

Arikayce liposomal

Norway

2.11.2020

EU/1/20/1469

Arikayce liposomal

Iceland

5.11.2020

EU/1/20/1475

Arsenic trioxide medac

Iceland

14.10.2020

EU/1/20/1475

Arsenic trioxide medac

Norway

29.9.2020

EU/1/20/1454

Aybintio

Iceland

25.8.2020

EU/120/1454

Aybintio

Liechtenstein

31.8.2020

EU/1/20/1454

Aybintio

Norway

25.8.2020

EU/1/20/1473

AYVAKYT

Iceland

14.10.2020

EU/1/20/1473

Ayvakyt

Norway

29.9.2020

EU/1/17/1214

Bavencio

Liechtenstein

31.8.2020

EU/1/20/1474

Blenrep

Iceland

14.9.2020

EU/1/20/1474

Blenrep

Liechtenstein

31.8.2020

EU/1/20/1474

Blenrep

Norway

2.9.2020

EU/1/19/1403

Budesonid/Formoterol Teva Pharma B.V.

Liechtenstein

31.8.2020

EU/1/20/1448

Cabazitaxel Accord

Iceland

3.9.2020

EU/1/20/1448

Cabazitaxel Accord

Norway

28.10.2020

EU/1/20/1479

Calquence

Iceland

10.11.2020

EU/1/20/1479

Calquence

Norway

11.11.2020

EU/2/20/264

Circomax Myco

Norway

16.12.2020

EU/1/20/1528

Comirnaty

Iceland

21.12.2020

EU/1/20/1528

Comirnaty

Norway

21.12.2020

EU/1/20/1451

Daurismo

Iceland

20.7.2020

EU/1/20/1451

Daurismo

Norway

3.7.2020

EU/1/20/1438

Enerzair Breezhaler

Iceland

21.7.2020

EU/1/20/1438

Enezair Breezhaler

Norway

14.7.2020

EU/2/20/262

Enteroporc Coli AC

Norway

16.12.2020

EU/1/20/1472

Equidacent

Iceland

14.10.2020

EU/1/20/1472

Equidacent

Norway

29.9.2020

EU/1/20/1489

Exparel liposomal

Iceland

3.12.2020

EU/1/20/1489

Exparel liposomal

Norway

24.11.2020

EU/1/20/1477

Fampridine Accord

Iceland

15.10.2020

EU/1/20/1477

Fampridine Accord

Norway

1.10.2020

EU/1/20/1450

Fingolimod Accord

Iceland

20.7.2020

EU/1/20/1450

Fingolimod Accord

Norway

13.7.2020

EU/1/20/1465

Gencebok

Iceland

25.8.2020

EU/1/20/1465

Gencebok

Liechtenstein

31.8.2020

EU/1/20/1465

Gencebok

Norway

2.9.2020

EU/1/20/1446

Hepcludex

Iceland

12.8.2020

EU/1/20/1446

Hepcludex

Liechtenstein

31.8.2020

EU/1/20/1446

Hepcludex

Norway

10.8.2020

EU/1/20/1471

Idefirix

Iceland

2.9.2020

EU/1/20/1471

Idefirix

Liechtenstein

31.8.2020

EU/1/20/1471

Idefirix

Norway

8.9.2020

EU/2/20/258

Increxxa

Iceland

21.9.2020

EU/2/20/256

Innovax-ND-ILT

Iceland

16.10.2020

EU/1/20/1447

Insulin Aspart Sanofi

Iceland

20.7.2020

EU/1/20/144

Insulin aspart Sanofi

Norway

3.7.2020

EU/1/20/1480

Jyseleca

Iceland

14.10.2020

EU/1/20/1480

Jyseleca

Norway

30.9.2020

EU/1/20/1468

Kaftrio

Iceland

25.8.2020

EU/1/20/1468

Kaftrio

Liechtenstein

31.8.2020

EU/1/20/1468

Kaftrio

Norway

3.9.2020

EU/1/20/1494

Leqvio

Norway

15.12.2020

EU/2/20/261

Librela

Iceland

13.11.2020

EU/1/20/1462

Livogiva

Iceland

2.9.2020

EU/1/20/1462

Livogiva

Liechtenstein

31.8.2020

EU/1/20/1462

Livogiva

Norway

7.9.2020

EU/1/20/1483

MenQuadfi

Iceland

2.12.2020

EU/1/20/1483

MenQuadfi

Norway

30.11.2020

EU/1/20/1470

Methylthioninium chloride Cosmo

Iceland

27.8.2020

EU/1/20/1470

Methylthioninium chloride Cosmo

Norway

3.9.2020

EU/2/20/259

Mhyosphere PCV ID

Iceland

14.10.2020

EU/2/19/247

Mirataz

Norway

11.8.2020

EU/1/20/1445

Mvabea

Iceland

21.7.2020

EU/1/20/1445

Mvabea

Norway

13.7.2020

EU/2/20/265

Nobivac DP PLUS

Norway

17.12.2020

EU/1/20/1424

Nustendi

Liechtenstein

31.8.2020

EU/1/20/1486

Nyvepria

Iceland

3.12.2020

EU/1/20/1486

Nyvepria

Norway

24.11.2020

EU/1/20/1485

Obiltoxaximab SFL

Iceland

8.12.2020

EU/1/20/1485

Obiltoxaximab SFL

Norway

24.11.2020

EU/2/20/260

OvuGel

Iceland

8.12.2020

EU/1/20/1496

Oxlumo

Iceland

2.12.2020

EU/1/20/1496

Oxlumo

Norway

24.11.2020

EU/1/20/1487

PHELINUN

Iceland

3.12.2020

EU/1/20/1487

PHELINUN

Norway

2.12.2020

EU/1/20/1497

Phesgo

Norway

23.12.2020

EU/1/20/1455

Piqray

Iceland

11.8.2020

EU/1/20/1455

Piqray

Liechtenstein

31.8.2020

EU/1/20/1455

Piqray

Norway

10.8.2020

EU/1/20/1437

Pretomanid FGK

Iceland

12.8.2020

EU/1/20/1437

Pretomanid FGK

Liechtenstein

31.8.2020

EU/1/20/1437

Pretomanid FGK

Norway

10.8.2020

EU/2/20/254

Prevexxion RN

Iceland

10.8.2020

EU/2/20/254

Prevexxion RN

Norway

10.8.2020

EU/2/20/255

Prevexxion RN+HVT+IBD

Iceland

27.7.2020

EU/2/20/255

Prevexxion RN+HVT+IBD

Liechtenstein

31.8.2020

EU/1/20/1463

Qutavina

Iceland

2.9.2020

EU/1/20/1463

Qutavina

Liechtenstein

31.8.2020

EU/1/20/1463

Qutavina

Norway

7.9.2020

EU/1/20/1452

Reblozyl

Iceland

20.7.2020

EU/1/20/1452

Reblozyl

Norway

3.7.2020

EU/2/20/263

Rexxolide

Norway

16.12.2020

EU/1/20/1488

Rivaroxaban Accord

Iceland

1.12.2020

EU/1/20/1488

Rivaroxaban Accord

Norway

2.12.2020

EU/1/20/1460

Rozlytrek

Iceland

12.8.2020

EU/1/20/1460

Rozlytrek

Norway

10.8.2020

EU/1/20/1484

Supemtek

Iceland

1.12.2020

EU/1/20/1484

Supemtek

Norway

24.11.2020

EU/1/20/1492

Tecartus

Norway

30.12.2020

EU/1/20/1498

TRIXEO AEROSPHERE

Norway

16.12.2020

EU/2/20/257

Tulinovet

Iceland

21.9.2020

EU/2/20/257

Tulinovet

Norway

8.12.2020

EU/1/20/1459

Veklury

Iceland

3.7.2020

EU1/20/1459

Veklury

Liechtenstein

31.8.2020

EU/1/20/1459

Veklury

Norway

3.7.2020

EU/1/20/1481

Vocabria

Norway

30.12.2020

EU/1/20/1457

Xenleta

Iceland

11.8.2020

EU/1/20/1457

Xenleta

Liechtenstein

31.8.2020

EU/1/20/1457

Xenleta

Norway

10.8.2020

EU/1/20/1444

Zabdeno

Iceland

21.7.2020

EU/1/20/1444

Zabdeno

Liechtenstein

31.8.2020

EU/1/20/1444

Zabdeno

Norway

14.7.2020

EU/1/20/1456

Zercepac

Iceland

11.8.2020

EU/1/20/1456

Zercepac

Liechtenstein

31.8.2020

EU/1/20/1456

Zercepac

Norway

10.8.2020

EU/1/20/1440

Zimbus Breezhaler

Iceland

21.7.2020

EU/1/20/1440

Zimbus Breezhaler

Liechtenstein

31.8.2020

EU/1/20/1440

Zimbus Breezhaler

Norway

13.7.2020

EU/1/20/1478

ZYNRELEF

Iceland

16.10.2020

EU/1/20/1478

Zynrelef

Norway

1.10.2020

---

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July – 31 December 2020:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/12/794 | ADCETRIS | Iceland | 2.10.2020 |
| EU/1/12/794 | ADCETRIS | Liechtenstein | 31.8.2020 |
| EU/1/12/794 | ADCETRIS | Norway | 14.10.2020 |
| EU/1/15/1045 | Aripiprazole Accord | Iceland | 15.10.2020 |
| EU/1/15/1045 | Aripiprazole Accord | Norway | 9.10.2020 |
| EU/1/15/1029 | Aripiprazole Sandoz | Iceland | 20.7.2020 |
| EU/1/15/1029 | Aripiprazole Sandoz | Norway | 21.7.2020 |
| EU/1/15/1063 | Armisarte | Iceland | 25.8.2020 |
| EU/1/15/1063 | Armisarte | Liechtenstein | 31.8.2020 |
| EU/1/15/1063 | Armisarte | Norway | 28.8.2020 |
| EU/1/17/1214 | Bavencio | Iceland | 10.8.2020 |
| EU/1/17/1214 | Bavencio | Norway | 25.8.2020 |
| EU/1/15/1074 | Benepali | Iceland | 7.12.2020 |
| EU/1/15/1074 | Benepali | Norway | 26.11.2020 |
| EU/1/15/1073 | Briviact | Iceland | 19.10.2020 |
| EU/1/15/1073 | Briviact | Norway | 20.10.2020 |
| EU/2/15/183 | Canigen L4 | Iceland | 26.8.2020 |
| EU/1/15/1055 | CIAMBRA | Iceland | 11.8.2020 |
| EU/1/15/1055 | Ciambra | Norway | 10.8.2020 |
| EU/1/15/1054 | Cinacalcet Mylan | Iceland | 13.10.2020 |
| EU/1/15/1054 | Cinacalcet Mylan | Norway | 1.10.2020 |
| EU/1/15/1048 | Cotellic | Iceland | 17.7.2020 |
| EU/1/15/1048 | Cotellic | Norway | 3.7.2020 |
| EU/1/15/1036 | CRESEMBA | Iceland | 24.8.2020 |
| EU/1/15/1036 | Cresemba | Liechtenstein | 31.8.2020 |
| EU/1/15/1036 | Cresemba | Norway | 28.8.2020 |
| EU/1/15/1028 | Duloxetine Zentiva | Iceland | 24.8.2020 |
| EU/1/15/1028 | Duloxetine Zentiva | Liechtenstein | 31.8.2020 |
| EU/1/15/1028 | Duloxetine Zentiva | Norway | 2.9.2020 |
| EU/1/15/1051 | Ebymect | Iceland | 3.9.2020 |
| EU/1/15/1051 | Ebymect | Norway | 7.9.2020 |
| EU/1/15/1052 | Edistride | Iceland | 15.10.2020 |
| EU/1/15/1052 | Edistride | Norway | 1.10.2020 |
| EU/1/15/1046 | Elocta | Iceland | 25.8.2020 |
| EU/1/15/1046 | Elocta | Liechtenstein | 31.8.2020 |
| EU/1/15/1058 | Entresto | Iceland | 20.7.2020 |
| EU/1/15/1058 | Entresto | Norway | 3.7.2020 |
| EU/1/15/1069 | Episalvan | Iceland | 13.10.2020 |
| EU/1/15/1069 | Episalvan | Norway | 7.10.2020 |
| EU/1/15/1065 | Eptifibatide Accord | Iceland | 15.10.2020 |
| EU/1/15/1065 | Eptifibatide Accord | Norway | 8.10.2020 |
| EU/1/19/1392 | Ervebo | Iceland | 21.9.2020 |
| EU1/19/1392 | Ervebo | Liechtenstein | 31.8.2020 |
| EU/1/19/1392 | Ervebo | Norway | 21.9.2020 |
| EU/1/15/1075 | Feraccru | Iceland | 10.12.2020 |
| EU/1/15/1075 | Feraccru | Norway | 3.12.2020 |
| EU/2/15/185 | Fortekor Plus | Iceland | 10.8.2020 |
| EU/2/15/185 | Fortekor Plus | Liechtenstein | 31.8.2020 |
| EU/2/15/185 | Fortekor Plus | Norway | 10.8.2020 |
| EU/1/15/1061 | Genvoya | Iceland | 2.10.2020 |
| EU/1/15/1061 | Genvoya | Norway | 29.9.2020 |
| EU/1/11/677 | Gilenya | Iceland | 27.11.2020 |
| EU/1/11/677 | Gilenya | Norway | 23.11.2020 |
| EU/1/15/1008 | Hetlioz | Iceland | 20.7.2020 |
| EU/1/15/1008 | Hetlioz | Norway | 13.7.2020 |
| EU/1/15/1064 | Imlygic | Iceland | 7.12.2020 |
| EU/1/15/1064 | Imlygic | Norway | 23.11.2020 |
| EU/2/15/193 | Imrestor | Iceland | 16.10.2020 |
| EU/2/15/193 | Imrestor | Norway | 9.10.2020 |
| EU/1/15/1040 | Intuniv | Iceland | 17.7.2020 |
| EU/1/15/1040 | Intuniv | Norway | 3.7.2020 |
| EU/1/11/676 | Jevtana | Norway | 22.12.2020 |
| EU/1/15/1076 | Kovaltry | Iceland | 13.10.2020 |
| EU/1/15/1076 | Kovaltry | Norway | 7.10.2020 |
| EU/1/15/1060 | Kyprolis | Iceland | 17.7.2020 |
| EU/1/15/1060 | Kyprolis | Norway | 3.7.2020 |
| EU/1/15/1067 | Lopinavir/Ritonavir Mylan | Iceland | 27.11.2020 |
| EU/1/15/1067 | Lopinavir/Ritonavir Mylan | Norway | 24.11.2020 |
| EU/1/15/1078 | Natpar | Norway | 17.8.2020 |
| EU/1/16/1094 | Ninlaro | Iceland | 7.12.2020 |
| EU/2/15/186 | Novaquin | Iceland | 24.7.2020 |
| EU/2/15/186 | Novaquin | Norway | 10.8.2020 |
| EU/1/15/1043 | Nucala | Iceland | 24.8.2020 |
| EU/1/15/1043 | Nucala | Liechtenstein | 31.8.2020 |
| EU/1/15/1043 | Nucala | Norway | 19.8.2020 |
| EU/1/15/1035 | Obizur | Iceland | 9.12.2020 |
| EU/1/15/1035 | Obizur | Norway | 26.11.2020 |
| EU/1/15/1018 | Omidria | Iceland | 10.8.2020 |
| EU/1/15/1018 | Omidria | Liechtenstein | 31.8.2020 |
| EU/1/15/1018 | Omidria | Norway | 10.8.2020 |
| EU/1/15/1070 | Oncaspar | Iceland | 7.12.2020 |
| EU/1/15/1070 | Oncaspar | Norway | 26.11.2020 |
| EU/1/18/1345 | Ondexxya | Norway | 13.8.2020 |
| EU/1/15/1059 | Orkambi | Iceland | 7.12.2020 |
| EU/1/15/1059 | Orkambi | Norway | 23.11.2020 |
| EU/1/15/1071 | Pemetrexed Accord | Iceland | 6.11.2020 |
| EU1/15/1071 | Pemetrexed Accord | Norway | 9.10.2020 |
| EU/1/15/1057 | Pemetrexed Hospira | Iceland | 14.8.2020 |
| EU/1/15/1057 | Pemetrexed Hospira | Norway | 21.8.2020 |
| EU/1/15/1038 | Pemetrexed medac | Iceland | 26.8.2020 |
| EU/1/15/1038 | Pemetrexed medac | Liechtenstein | 31.8.2020 |
| EU/1/15/1038 | Pemetrexed medac | Norway | 3.9.2020 |
| EU/1/15/1037 | Pemetrexed Sandoz | Iceland | 31.8.2020 |
| EU/1/15/1037 | Pemetrexed Sandoz | Liechtenstein | 31.8.2020 |
| EU/1/15/1037 | Pemetrexed Sandoz | Norway | 3.9.2020 |
| EU/1/19/1388 | Polivy | Norway | 17.12.2020 |
| EU/1/15/1056 | Praxbind | Iceland | 11.8.2020 |
| EU/1/15/1056 | Praxbind | Liechtenstein | 31.8.2020 |
| EU/1/15/1056 | Praxbind | Norway | 10.8.2020 |
| EU/1/15/1027 | Pregabalin Accord | Iceland | 20.7.2020 |
| EU/1/15/1027 | Pregabalin Accord | Liechtenstein | 31.8.2020 |
| EU/1/15/1027 | Pregabalin Accord | Norway | 14.7.2020 |
| EU/1/15/1011 | Pregabalin Sandoz | Iceland | 17.7.2020 |
| EU/1/15/1011 | Pregabalin Sandoz | Norway | 13.7.2020 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Iceland | 17.7.2020 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Norway | 13.7.2020 |
| EU/1/10/618 | Prolia | Norway | 14.8.2020 |
| EU/1/16/1090 | Rasagiline Mylan | Iceland | 9.12.2020 |
| EU/1/16/1090 | Rasagiline Mylan | Norway | 26.11.2020 |
| EU/1/15/1062 | Ravicti | Iceland | 27.8.2020 |
| EU/1/15/1062 | Ravicti | Liechtenstein | 31.8.2020 |
| EU/1/15/1062 | Ravicti | Norway | 3.9.2020 |
| EU/1/15/1020 | Raxone | Iceland | 14.8.2020 |
| EU/1/15/1020 | Raxone | Liechtenstein | 31.8.2020 |
| EU/1/15/1020 | Raxone | Norway | 19.8.2020 |
| EU/2/15/191 | Simparica | Iceland | 26.8.2020 |
| EU/2/15/191 | Simparica | Liechtenstein | 31.8.2020 |
| EU/2/15/191 | Simparica | Norway | 2.9.2020 |
| EU/1/15/1072 | Spectrila | Iceland | 15.10.2020 |
| EU/1/15/1072 | Spectrila | Norway | 29.9.2020 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Iceland | 21.9.2020 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Liechtenstein | 31.8.2020 |
| EU/2/15/190 | Suvaxyn Circo + MH RTU | Norway | 29.9.2020 |
| EU/1/13/902 | Translarna | Iceland | 11.8.2020 |
| EU/1/13/902 | Translarna | Norway | 20.8.2020 |
| EU/2/15/184 | UpCard | Iceland | 17.7.2020 |
| EU/2/15/184 | Upcard | Norway | 3.7.2020 |
| EU/1/15/1083 | Uptravi | Norway | 21.12.2020 |
| EU/1/15/1079 | VAXELIS | Iceland | 13.10.2020 |
| EU/1/15/1079 | Vaxelis | Norway | 15.10.2020 |
| EU/2/15/188 | Vectormune ND | Liechtenstein | 31.8.2020 |
| EU/2/15/188 | Vectormune ND | Norway | 29.7.2020 |
| EU/1/19/1385 | VITRAKVI | Iceland | 28.8.2020 |
| EU/1/19/1385 | VITRAKVI | Liechtenstein | 31.8.2020 |
| EU/1/19/1385 | VITRAKVI | Norway | 7.9.2020 |
| EU/1/11/710 | Votubia | Iceland | 10.8.2020 |
| EU/1/11/710 | Votubia | Liechtenstein | 31.8.2020 |
| EU/1/11/710 | Votubia | Norway | 10.8.2020 |
| EU/1/10/646 | VPRIV | Iceland | 10.8.2020 |
| EU/1/10/646 | VPRIV | Liechtenstein | 31.8.2020 |
| EU/1/10/646 | VPRIV | Norway | 10.8.2020 |
| EU/1/15/1042 | Zalviso | Iceland | 15.10.2020 |
| EU/1/15/1042 | Zalviso | Norway | 7.10.2020 |
| EU/1/16/1093 | Zonisamide Mylan | Norway | 15.12.2020 |
| EU/2/15/189 | Zycortal | Iceland | 27.8.2020 |
| EU/2/15/189 | Zycortal | Liechtenstein | 31.8.2020 |
| EU/2//15/189 | Zycortal | Norway | 3.9.2020 |

EU-Number

Product

Country

Date of authorisation

EU/1/12/794

ADCETRIS

Iceland

2.10.2020

EU/1/12/794

ADCETRIS

Liechtenstein

31.8.2020

EU/1/12/794

ADCETRIS

Norway

14.10.2020

EU/1/15/1045

Aripiprazole Accord

Iceland

15.10.2020

EU/1/15/1045

Aripiprazole Accord

Norway

9.10.2020

EU/1/15/1029

Aripiprazole Sandoz

Iceland

20.7.2020

EU/1/15/1029

Aripiprazole Sandoz

Norway

21.7.2020

EU/1/15/1063

Armisarte

Iceland

25.8.2020

EU/1/15/1063

Armisarte

Liechtenstein

31.8.2020

EU/1/15/1063

Armisarte

Norway

28.8.2020

EU/1/17/1214

Bavencio

Iceland

10.8.2020

EU/1/17/1214

Bavencio

Norway

25.8.2020

EU/1/15/1074

Benepali

Iceland

7.12.2020

EU/1/15/1074

Benepali

Norway

26.11.2020

EU/1/15/1073

Briviact

Iceland

19.10.2020

EU/1/15/1073

Briviact

Norway

20.10.2020

EU/2/15/183

Canigen L4

Iceland

26.8.2020

EU/1/15/1055

CIAMBRA

Iceland

11.8.2020

EU/1/15/1055

Ciambra

Norway

10.8.2020

EU/1/15/1054

Cinacalcet Mylan

Iceland

13.10.2020

EU/1/15/1054

Cinacalcet Mylan

Norway

1.10.2020

EU/1/15/1048

Cotellic

Iceland

17.7.2020

EU/1/15/1048

Cotellic

Norway

3.7.2020

EU/1/15/1036

CRESEMBA

Iceland

24.8.2020

EU/1/15/1036

Cresemba

Liechtenstein

31.8.2020

EU/1/15/1036

Cresemba

Norway

28.8.2020

EU/1/15/1028

Duloxetine Zentiva

Iceland

24.8.2020

EU/1/15/1028

Duloxetine Zentiva

Liechtenstein

31.8.2020

EU/1/15/1028

Duloxetine Zentiva

Norway

2.9.2020

EU/1/15/1051

Ebymect

Iceland

3.9.2020

EU/1/15/1051

Ebymect

Norway

7.9.2020

EU/1/15/1052

Edistride

Iceland

15.10.2020

EU/1/15/1052

Edistride

Norway

1.10.2020

EU/1/15/1046

Elocta

Iceland

25.8.2020

EU/1/15/1046

Elocta

Liechtenstein

31.8.2020

EU/1/15/1058

Entresto

Iceland

20.7.2020

EU/1/15/1058

Entresto

Norway

3.7.2020

EU/1/15/1069

Episalvan

Iceland

13.10.2020

EU/1/15/1069

Episalvan

Norway

7.10.2020

EU/1/15/1065

Eptifibatide Accord

Iceland

15.10.2020

EU/1/15/1065

Eptifibatide Accord

Norway

8.10.2020

EU/1/19/1392

Ervebo

Iceland

21.9.2020

EU1/19/1392

Ervebo

Liechtenstein

31.8.2020

EU/1/19/1392

Ervebo

Norway

21.9.2020

EU/1/15/1075

Feraccru

Iceland

10.12.2020

EU/1/15/1075

Feraccru

Norway

3.12.2020

EU/2/15/185

Fortekor Plus

Iceland

10.8.2020

EU/2/15/185

Fortekor Plus

Liechtenstein

31.8.2020

EU/2/15/185

Fortekor Plus

Norway

10.8.2020

EU/1/15/1061

Genvoya

Iceland

2.10.2020

EU/1/15/1061

Genvoya

Norway

29.9.2020

EU/1/11/677

Gilenya

Iceland

27.11.2020

EU/1/11/677

Gilenya

Norway

23.11.2020

EU/1/15/1008

Hetlioz

Iceland

20.7.2020

EU/1/15/1008

Hetlioz

Norway

13.7.2020

EU/1/15/1064

Imlygic

Iceland

7.12.2020

EU/1/15/1064

Imlygic

Norway

23.11.2020

EU/2/15/193

Imrestor

Iceland

16.10.2020

EU/2/15/193

Imrestor

Norway

9.10.2020

EU/1/15/1040

Intuniv

Iceland

17.7.2020

EU/1/15/1040

Intuniv

Norway

3.7.2020

EU/1/11/676

Jevtana

Norway

22.12.2020

EU/1/15/1076

Kovaltry

Iceland

13.10.2020

EU/1/15/1076

Kovaltry

Norway

7.10.2020

EU/1/15/1060

Kyprolis

Iceland

17.7.2020

EU/1/15/1060

Kyprolis

Norway

3.7.2020

EU/1/15/1067

Lopinavir/Ritonavir Mylan

Iceland

27.11.2020

EU/1/15/1067

Lopinavir/Ritonavir Mylan

Norway

24.11.2020

EU/1/15/1078

Natpar

Norway

17.8.2020

EU/1/16/1094

Ninlaro

Iceland

7.12.2020

EU/2/15/186

Novaquin

Iceland

24.7.2020

EU/2/15/186

Novaquin

Norway

10.8.2020

EU/1/15/1043

Nucala

Iceland

24.8.2020

EU/1/15/1043

Nucala

Liechtenstein

31.8.2020

EU/1/15/1043

Nucala

Norway

19.8.2020

EU/1/15/1035

Obizur

Iceland

9.12.2020

EU/1/15/1035

Obizur

Norway

26.11.2020

EU/1/15/1018

Omidria

Iceland

10.8.2020

EU/1/15/1018

Omidria

Liechtenstein

31.8.2020

EU/1/15/1018

Omidria

Norway

10.8.2020

EU/1/15/1070

Oncaspar

Iceland

7.12.2020

EU/1/15/1070

Oncaspar

Norway

26.11.2020

EU/1/18/1345

Ondexxya

Norway

13.8.2020

EU/1/15/1059

Orkambi

Iceland

7.12.2020

EU/1/15/1059

Orkambi

Norway

23.11.2020

EU/1/15/1071

Pemetrexed Accord

Iceland

6.11.2020

EU1/15/1071

Pemetrexed Accord

Norway

9.10.2020

EU/1/15/1057

Pemetrexed Hospira

Iceland

14.8.2020

EU/1/15/1057

Pemetrexed Hospira

Norway

21.8.2020

EU/1/15/1038

Pemetrexed medac

Iceland

26.8.2020

EU/1/15/1038

Pemetrexed medac

Liechtenstein

31.8.2020

EU/1/15/1038

Pemetrexed medac

Norway

3.9.2020

EU/1/15/1037

Pemetrexed Sandoz

Iceland

31.8.2020

EU/1/15/1037

Pemetrexed Sandoz

Liechtenstein

31.8.2020

EU/1/15/1037

Pemetrexed Sandoz

Norway

3.9.2020

EU/1/19/1388

Polivy

Norway

17.12.2020

EU/1/15/1056

Praxbind

Iceland

11.8.2020

EU/1/15/1056

Praxbind

Liechtenstein

31.8.2020

EU/1/15/1056

Praxbind

Norway

10.8.2020

EU/1/15/1027

Pregabalin Accord

Iceland

20.7.2020

EU/1/15/1027

Pregabalin Accord

Liechtenstein

31.8.2020

EU/1/15/1027

Pregabalin Accord

Norway

14.7.2020

EU/1/15/1011

Pregabalin Sandoz

Iceland

17.7.2020

EU/1/15/1011

Pregabalin Sandoz

Norway

13.7.2020

EU/1/15/1012

Pregabalin Sandoz GmbH

Iceland

17.7.2020

EU/1/15/1012

Pregabalin Sandoz GmbH

Norway

13.7.2020

EU/1/10/618

Prolia

Norway

14.8.2020

EU/1/16/1090

Rasagiline Mylan

Iceland

9.12.2020

EU/1/16/1090

Rasagiline Mylan

Norway

26.11.2020

EU/1/15/1062

Ravicti

Iceland

27.8.2020

EU/1/15/1062

Ravicti

Liechtenstein

31.8.2020

EU/1/15/1062

Ravicti

Norway

3.9.2020

EU/1/15/1020

Raxone

Iceland

14.8.2020

EU/1/15/1020

Raxone

Liechtenstein

31.8.2020

EU/1/15/1020

Raxone

Norway

19.8.2020

EU/2/15/191

Simparica

Iceland

26.8.2020

EU/2/15/191

Simparica

Liechtenstein

31.8.2020

EU/2/15/191

Simparica

Norway

2.9.2020

EU/1/15/1072

Spectrila

Iceland

15.10.2020

EU/1/15/1072

Spectrila

Norway

29.9.2020

EU/2/15/190

Suvaxyn Circo + MH RTU

Iceland

21.9.2020

EU/2/15/190

Suvaxyn Circo + MH RTU

Liechtenstein

31.8.2020

EU/2/15/190

Suvaxyn Circo + MH RTU

Norway

29.9.2020

EU/1/13/902

Translarna

Iceland

11.8.2020

EU/1/13/902

Translarna

Norway

20.8.2020

EU/2/15/184

UpCard

Iceland

17.7.2020

EU/2/15/184

Upcard

Norway

3.7.2020

EU/1/15/1083

Uptravi

Norway

21.12.2020

EU/1/15/1079

VAXELIS

Iceland

13.10.2020

EU/1/15/1079

Vaxelis

Norway

15.10.2020

EU/2/15/188

Vectormune ND

Liechtenstein

31.8.2020

EU/2/15/188

Vectormune ND

Norway

29.7.2020

EU/1/19/1385

VITRAKVI

Iceland

28.8.2020

EU/1/19/1385

VITRAKVI

Liechtenstein

31.8.2020

EU/1/19/1385

VITRAKVI

Norway

7.9.2020

EU/1/11/710

Votubia

Iceland

10.8.2020

EU/1/11/710

Votubia

Liechtenstein

31.8.2020

EU/1/11/710

Votubia

Norway

10.8.2020

EU/1/10/646

VPRIV

Iceland

10.8.2020

EU/1/10/646

VPRIV

Liechtenstein

31.8.2020

EU/1/10/646

VPRIV

Norway

10.8.2020

EU/1/15/1042

Zalviso

Iceland

15.10.2020

EU/1/15/1042

Zalviso

Norway

7.10.2020

EU/1/16/1093

Zonisamide Mylan

Norway

15.12.2020

EU/2/15/189

Zycortal

Iceland

27.8.2020

EU/2/15/189

Zycortal

Liechtenstein

31.8.2020

EU/2//15/189

Zycortal

Norway

3.9.2020

---

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July – 31 December 2020:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/14/980/008-011 | Cosentyx | Iceland | 9.12.2020 |
| EU/1/14/980/008-011 | Cosentyx | Norway | 30.11.2020 |
| EU/1/16/1116/002 | Epclusa | Iceland | 31.8.2020 |
| EU/1/16/1116/002 | Epclusa | Norway | 3.9.2020 |
| EU/1/14/958/003-005 | Harvoni | Iceland | 21.7.2020 |
| EU/1/14/958 | Harvoni | Norway | 14.7.2020 |
| EU/1/16/1095/009 | IDELVION | Iceland | 27.8.2020 |
| EU/1/16/1095/009 | IDELVION | Norway | 3.9.2020 |
| EU/1/12/782/007 | Kalydeco | Iceland | 9.12.2020 |
| EU/1/12/782 | Kalydeco | Norway | 25.11.2020 |
| EU/1/15/1071/004-007 | Pemetrexed Accord | Iceland | 8.12.2020 |
| EU/1/15/1071 | Pemetrexed Accord | Norway | 16.11.2020 |
| EU/1/15/1057/004-006 | Pemetrexed Hospira | Iceland | 15.10.2020 |
| EU/1/15/1057 | Pemetrexed Hospira | Norway | 30.9.2020 |
| EU/1/14/934 | Plegridy | Norway | 14.12.2020 |
| EU/1/15/1031/019-020 | Praluent | Iceland | 24.8.2020 |
| EU/1/13/894/003-005 | Sovaldi | Iceland | 20.7.2020 |
| EU/1/13/894 | Sovaldi | Norway | 3.7.2020 |
| EU/1/06/359/007-018 | Suboxone | Iceland | 21.7.2020 |
| EU/1/06/359/007-018 | Suboxone | Norway | 17.7.2020 |
| EU/1/18/1306/002 | Symkevi | Iceland | 9.12.2020 |
| EU/1/18/1306 | Symkevi | Norway | 25.11.2020 |
| EU/1/14/956/011-016 | Trulicity | Iceland | 9.12.2020 |
| EU/1/14/956/011-016 | Trulicity | Norway | 2.12.2020 |
| EU/1/19/1371/002-003 | Ultomiris | Iceland | 3.12.2020 |
| EU/1/19/1371/002-003 | Ultomiris | Norway | 25.11.2020 |
| EU/1/14/943/005 | Velphoro | Iceland | 27.11.2020 |
| EU/1/14/943/005 | Velphoro | Norway | 23.11.2020 |

EU-Number

Product

Country

Date of authorisation

EU/1/14/980/008-011

Cosentyx

Iceland

9.12.2020

EU/1/14/980/008-011

Cosentyx

Norway

30.11.2020

EU/1/16/1116/002

Epclusa

Iceland

31.8.2020

EU/1/16/1116/002

Epclusa

Norway

3.9.2020

EU/1/14/958/003-005

Harvoni

Iceland

21.7.2020

EU/1/14/958

Harvoni

Norway

14.7.2020

EU/1/16/1095/009

IDELVION

Iceland

27.8.2020

EU/1/16/1095/009

IDELVION

Norway

3.9.2020

EU/1/12/782/007

Kalydeco

Iceland

9.12.2020

EU/1/12/782

Kalydeco

Norway

25.11.2020

EU/1/15/1071/004-007

Pemetrexed Accord

Iceland

8.12.2020

EU/1/15/1071

Pemetrexed Accord

Norway

16.11.2020

EU/1/15/1057/004-006

Pemetrexed Hospira

Iceland

15.10.2020

EU/1/15/1057

Pemetrexed Hospira

Norway

30.9.2020

EU/1/14/934

Plegridy

Norway

14.12.2020

EU/1/15/1031/019-020

Praluent

Iceland

24.8.2020

EU/1/13/894/003-005

Sovaldi

Iceland

20.7.2020

EU/1/13/894

Sovaldi

Norway

3.7.2020

EU/1/06/359/007-018

Suboxone

Iceland

21.7.2020

EU/1/06/359/007-018

Suboxone

Norway

17.7.2020

EU/1/18/1306/002

Symkevi

Iceland

9.12.2020

EU/1/18/1306

Symkevi

Norway

25.11.2020

EU/1/14/956/011-016

Trulicity

Iceland

9.12.2020

EU/1/14/956/011-016

Trulicity

Norway

2.12.2020

EU/1/19/1371/002-003

Ultomiris

Iceland

3.12.2020

EU/1/19/1371/002-003

Ultomiris

Norway

25.11.2020

EU/1/14/943/005

Velphoro

Iceland

27.11.2020

EU/1/14/943/005

Velphoro

Norway

23.11.2020

---

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July – 31 December 2020:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/18/1269 | Alpivab | Iceland | 9.12.2020 |
| EU/1/18/1269 | Alpivab | Norway | 10.12.2020 |
| EU/1/10/623 | Clopidogrel/Acetylsalicylic acid Zentiva | Iceland | 14.8.2020 |
| EU/1/18/1300 | Duzallo | Iceland | 11.8.2020 |
| EU/1/18/1300 | Duzallo | Norway | 10.9.2020 |
| EU/1/13/895 | Kolbam | Iceland | 20.7.2020 |
| EU/1/13/895 | Kolbam | Norway | 11.8.2020 |
| EU/1/00/149 | Panretin | Iceland | 13.11.2020 |
| EU/1/19/1401 | Qtrilmet | Iceland | 24.8.2020 |
| EU/1/19/1401 | Qtrilmet | Liechtenstein | 31.8.2020 |
| EU/1/19/1401 | Qtrilmet | Norway | 8.10.2020 |
| EU/1/20/1463 | Qutavina | Iceland | 10.12.2020 |
| EU/1/20/1463 | Qutavina | Norway | 18.12.2020 |
| EU/1/10/634 | Ribavirin Mylan | Iceland | 5.11.2020 |
| EU/1/10/634 | Ribavirin Mylan | Norway | 5.11.2020 |
| EU/1/07/388 | Sebivo | Iceland | 27.11.2020 |
| EU/1/07/388 | Sebivo | Norway | 23.11.2020 |
| EU/2/09/099 | Suvaxyn PCV | Iceland | 24.7.2020 |
| EU/1/12/752 | Vepacel | Iceland | 14.10.2020 |
| EU/1/12/752 | Vepacel | Norway | 8.10.2020 |
| EU/1/96/009 | Zerit | Iceland | 17.7.2020 |
| EU/1/96/009 | Zerit | Norway | 8.7.2020 |
| EU/2/09/105 | Zulvac 8 Bovis | Iceland | 12.11.2020 |
| EU/2/09/105 | Zulvac 8 Bovis | Norway | 11.11.2020 |
| EU/1/15/1080 | Zurampic | Iceland | 12.8.2020 |
| EU/1/15/1080 | Zurampic | Liechtenstein | 31.8.2020 |
| EU/1/15/1080 | Zurampic | Norway | 10.9.2020 |

EU-Number

Product

Country

Date of withdrawal

EU/1/18/1269

Alpivab

Iceland

9.12.2020

EU/1/18/1269

Alpivab

Norway

10.12.2020

EU/1/10/623

Clopidogrel/Acetylsalicylic acid Zentiva

Iceland

14.8.2020

EU/1/18/1300

Duzallo

Iceland

11.8.2020

EU/1/18/1300

Duzallo

Norway

10.9.2020

EU/1/13/895

Kolbam

Iceland

20.7.2020

EU/1/13/895

Kolbam

Norway

11.8.2020

EU/1/00/149

Panretin

Iceland

13.11.2020

EU/1/19/1401

Qtrilmet

Iceland

24.8.2020

EU/1/19/1401

Qtrilmet

Liechtenstein

31.8.2020

EU/1/19/1401

Qtrilmet

Norway

8.10.2020

EU/1/20/1463

Qutavina

Iceland

10.12.2020

EU/1/20/1463

Qutavina

Norway

18.12.2020

EU/1/10/634

Ribavirin Mylan

Iceland

5.11.2020

EU/1/10/634

Ribavirin Mylan

Norway

5.11.2020

EU/1/07/388

Sebivo

Iceland

27.11.2020

EU/1/07/388

Sebivo

Norway

23.11.2020

EU/2/09/099

Suvaxyn PCV

Iceland

24.7.2020

EU/1/12/752

Vepacel

Iceland

14.10.2020

EU/1/12/752

Vepacel

Norway

8.10.2020

EU/1/96/009

Zerit

Iceland

17.7.2020

EU/1/96/009

Zerit

Norway

8.7.2020

EU/2/09/105

Zulvac 8 Bovis

Iceland

12.11.2020

EU/2/09/105

Zulvac 8 Bovis

Norway

11.11.2020

EU/1/15/1080

Zurampic

Iceland

12.8.2020

EU/1/15/1080

Zurampic

Liechtenstein

31.8.2020

EU/1/15/1080

Zurampic

Norway

10.9.2020

---

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July – 31 December 2020:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/12/750 | Esmya | Iceland | 26.8.2020 |
| EU/1/18/1309 | Ulipristal Acetate Gedeon Richter 5 | Iceland | 26.8.2020 |

EU-Number

Product

Country

Date of suspension

EU/1/12/750

Esmya

Iceland

26.8.2020

EU/1/18/1309

Ulipristal Acetate Gedeon Richter 5

Iceland

26.8.2020

---

V Announcements

COURT PROCEEDINGS

EFTA Court

| 12.8.2021 | EN | Official Journal of the European Union | C 324/29 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/29

---

JUDGMENT OF THE COURT

of 21 April 2021

in Case E-2/20

The Norwegian Government, represented by the Immigration Appeals Board (Utlendingsnemnda – UNE) v L

(Directive 2004/38/EC – Freedom of movement and residence – Expulsion – Protection against expulsion – Genuine, present and sufficiently serious threat – Imperative grounds of public security – Exclusion orders – Applications for lifting of exclusion orders –Material change – Necessity – Proportionality – Fundamental rights – Right to family life)

(2021/C 324/11)

In Case E-2/20, The Norwegian Government, represented by the Immigration Appeals Board (Utlendingsnemnda – UNE) v L – REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice by Borgarting Court of Appeal (Borgarting lagmannsrett) concerning the interpretation of Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States, as adapted to the Agreement on the European Economic Area, the Court, composed of Páll Hreinsson, President, Per Christiansen and Bernd Hammermann (Judge-Rapporteur), Judges, gave judgment on 21 April 2021, the operative part of which is as follows:

| 1. | Permanent exclusion orders are, in principle, not contrary to EEA law, provided that they satisfy the conditions set out in Articles 27 and 28 of Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States and may be lifted in accordance with Article 32 thereof. An expulsion measure must be based on an individual examination. As regards EEA nationals who have legally resided for a period of more than 10 years in the host State, expulsions may only be adopted, pursuant to Articles 27 and 28(3) of Directive 2004/38/EC, on imperative grounds of public security, in circumstances where the personal conduct of the individual concerned poses an exceptionally serious threat that an expulsion measure is necessary for the protection of one of the fundamental interests of society. This is provided that such protection cannot be attained by less strict means, having regard to the length of residence of the EEA national in the host State, and in particular to the serious negative consequences such a measure may have for an EEA national and his/her family members who have become genuinely integrated into the host State. Any subsequent exclusion decision must be limited to what is necessary to safeguard the fundamental interest that the expulsion intended to protect. The exclusion decision must adhere to the principle of proportionality. |
| --- | --- |

1.

Permanent exclusion orders are, in principle, not contrary to EEA law, provided that they satisfy the conditions set out in Articles 27 and 28 of Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States and may be lifted in accordance with Article 32 thereof. An expulsion measure must be based on an individual examination. As regards EEA nationals who have legally resided for a period of more than 10 years in the host State, expulsions may only be adopted, pursuant to Articles 27 and 28(3) of Directive 2004/38/EC, on imperative grounds of public security, in circumstances where the personal conduct of the individual concerned poses an exceptionally serious threat that an expulsion measure is necessary for the protection of one of the fundamental interests of society. This is provided that such protection cannot be attained by less strict means, having regard to the length of residence of the EEA national in the host State, and in particular to the serious negative consequences such a measure may have for an EEA national and his/her family members who have become genuinely integrated into the host State. Any subsequent exclusion decision must be limited to what is necessary to safeguard the fundamental interest that the expulsion intended to protect. The exclusion decision must adhere to the principle of proportionality.

| 2. | Social rehabilitation of an EEA national in the State in which he/she has become genuinely integrated is in the interest of the society in general. The good behaviour of the individual concerned during the period of imprisonment and subsequently, under probation, together with other evidence of re-integration into society mitigate against a present threat to public security. Family and children of the individual, including step-children, are an important consideration in the assessment of the necessity of a restrictive measure under Chapter VI of Directive 2004/38/EC in light of the principle of proportionality, of the child’s best interests, and of fundamental rights. In assessing the necessity of the expulsion, consideration of any alternatives to the expulsion must be part of the overall assessment. |
| --- | --- |

2.

Social rehabilitation of an EEA national in the State in which he/she has become genuinely integrated is in the interest of the society in general. The good behaviour of the individual concerned during the period of imprisonment and subsequently, under probation, together with other evidence of re-integration into society mitigate against a present threat to public security. Family and children of the individual, including step-children, are an important consideration in the assessment of the necessity of a restrictive measure under Chapter VI of Directive 2004/38/EC in light of the principle of proportionality, of the child’s best interests, and of fundamental rights. In assessing the necessity of the expulsion, consideration of any alternatives to the expulsion must be part of the overall assessment.

| 3. | A material change for the purposes of Article 32 of Directive 2004/38/EC is one that removes the justification for the initial decision under Chapter VI of the directive to restrict freedom of movement based on the individual’s conduct. It cannot be assumed that a material change in personal conduct will not occur and each application must be assessed on a case-by-case basis. Account must be taken of all factors which could provide evidence of a material change in personal conduct. This will depend on the nature of the individual’s conduct and the threat to society it presented. Any evidence showing that the individual has engaged in positive and legal activities such that it is unlikely that he/she would revert to the type of activities that led to the expulsion must be taken into account. Such factors could include, but are not limited to, evidence that a person has refrained from engaging in further criminality, evidence of reintegration in the host society, starting and keeping up a stable economic activity, the results of psychological assessments, credible expressions of remorse, evidence of having engaged positively and constructively in society, and in particular the social rehabilitation of the EEA national in the State in which he/she has become genuinely integrated. |
| --- | --- |

3.

A material change for the purposes of Article 32 of Directive 2004/38/EC is one that removes the justification for the initial decision under Chapter VI of the directive to restrict freedom of movement based on the individual’s conduct. It cannot be assumed that a material change in personal conduct will not occur and each application must be assessed on a case-by-case basis. Account must be taken of all factors which could provide evidence of a material change in personal conduct. This will depend on the nature of the individual’s conduct and the threat to society it presented. Any evidence showing that the individual has engaged in positive and legal activities such that it is unlikely that he/she would revert to the type of activities that led to the expulsion must be taken into account. Such factors could include, but are not limited to, evidence that a person has refrained from engaging in further criminality, evidence of reintegration in the host society, starting and keeping up a stable economic activity, the results of psychological assessments, credible expressions of remorse, evidence of having engaged positively and constructively in society, and in particular the social rehabilitation of the EEA national in the State in which he/she has become genuinely integrated.

---

| 12.8.2021 | EN | Official Journal of the European Union | C 324/31 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/31

---

JUDGMENT OF THE COURT

of 5 May 2021

in Case E-8/20

Criminal proceedings against N

(Freedom to receive services – Freedom of movement for workers – Regulation (EEC) No 1408/71 – Regulation (EC) No 883/2004 – Retention of social security benefits in another EEA State – Sickness benefit – Stay – Restriction of a fundamental freedom – Justification)

(2021/C 324/12)

In Case E-8/20, Criminal proceedings against N – REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice by the Supreme Court of Norway (Norges Høyesterett) concerning the interpretation of the Agreement on the European Economic Area, in particular Articles 28 and 36, Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community, Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems and Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States, the Court, composed of Páll Hreinsson, President (Judge-Rapporteur), Per Christiansen and Bernd Hammermann, Judges, gave judgment on 5 May 2021, the operative part of which is as follows:

| 1. | The answer to the first and twelfth questions is that a benefit such as the work assessment allowance at issue in the main proceedings constitutes a sickness benefit within the meaning of point (a) of Article 4(1) of Regulation (EEC) No 1408/71 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community and point (a) of Article 3(1) of Regulation (EC) No 883/2004 on the coordination of social security systems. |
| --- | --- |

1.

The answer to the first and twelfth questions is that a benefit such as the work assessment allowance at issue in the main proceedings constitutes a sickness benefit within the meaning of point (a) of Article 4(1) of Regulation (EEC) No 1408/71 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community and point (a) of Article 3(1) of Regulation (EC) No 883/2004 on the coordination of social security systems.

| 2. | The answer to the second, third, and fourth questions must be that a situation such as that at issue in the main proceedings does not come within the scope of Articles 19 or 22 of Regulation (EEC) No 1408/71. However, that finding does not have the effect of removing national rules such as those at issue in the main proceedings from the scope of the provisions of the main part of the EEA Agreement or another legal act incorporated into the EEA Agreement. |
| --- | --- |

2.

The answer to the second, third, and fourth questions must be that a situation such as that at issue in the main proceedings does not come within the scope of Articles 19 or 22 of Regulation (EEC) No 1408/71. However, that finding does not have the effect of removing national rules such as those at issue in the main proceedings from the scope of the provisions of the main part of the EEA Agreement or another legal act incorporated into the EEA Agreement.

| 3. | The answer to the fifth, sixth, seventh, and eight questions must be that Article 36 EEA must be interpreted as precluding legislation of an EEA State, such as that at issue in the main proceedings, which makes the right of insured persons to retain sickness benefits in cash within the meaning of point (a) of Article 4(1) of Regulation (EEC) No 1408/71 in the case of a stay in another EEA State subject to






  — | a requirement that the recipient of sickness benefits may stay abroad only for a limited period of time which may not usually exceed four weeks per year; and |
| --- | --- | --- |

3.

The answer to the fifth, sixth, seventh, and eight questions must be that Article 36 EEA must be interpreted as precluding legislation of an EEA State, such as that at issue in the main proceedings, which makes the right of insured persons to retain sickness benefits in cash within the meaning of point (a) of Article 4(1) of Regulation (EEC) No 1408/71 in the case of a stay in another EEA State subject to

—

a requirement that the recipient of sickness benefits may stay abroad only for a limited period of time which may not usually exceed four weeks per year; and

| — | a system of prior authorisation, which provides for such authorisation to be refused unless it can be demonstrated that the stay in another EEA State is compatible with the performance of defined activity obligations and does not impede follow-up and control by the competent institution. |
| --- | --- |

—

a system of prior authorisation, which provides for such authorisation to be refused unless it can be demonstrated that the stay in another EEA State is compatible with the performance of defined activity obligations and does not impede follow-up and control by the competent institution.

| 4. | In light of the answer given to the fifth, sixth, seventh and eighth questions, it is not necessary to answer the ninth, tenth and eleventh questions. |
| --- | --- |

4.

In light of the answer given to the fifth, sixth, seventh and eighth questions, it is not necessary to answer the ninth, tenth and eleventh questions.

| 5. | The answer to the thirteenth question must be that the term ‘staying’ in Article 21(1) of Regulation (EC) No 883/2004 must be interpreted as encompassing short-term stays in another EEA State not constituting ‘residence’ within the meaning of point (j) of Article 1 of that regulation, such as those at issue in the main proceedings. |
| --- | --- |

5.

The answer to the thirteenth question must be that the term ‘staying’ in Article 21(1) of Regulation (EC) No 883/2004 must be interpreted as encompassing short-term stays in another EEA State not constituting ‘residence’ within the meaning of point (j) of Article 1 of that regulation, such as those at issue in the main proceedings.

| 6. | The answer to the fourteenth question must be that Article 21 of Regulation (EC) No 883/2004 must be interpreted as covering situations where a medical diagnosis is given during a stay in an EEA State other than the competent EEA State as well as situations where, as in the main proceedings, the diagnosis is recognised by the competent institution before departure. |
| --- | --- |

6.

The answer to the fourteenth question must be that Article 21 of Regulation (EC) No 883/2004 must be interpreted as covering situations where a medical diagnosis is given during a stay in an EEA State other than the competent EEA State as well as situations where, as in the main proceedings, the diagnosis is recognised by the competent institution before departure.

| 7. | The answer to the fifteenth question must be that Article 21(1) of Regulation (EC) No 883/2004 must be interpreted as precluding conditions such as






  (i) | that the benefit may be provided only for a maximum of four weeks per year outside of Norway; |
| --- | --- | --- |

7.

The answer to the fifteenth question must be that Article 21(1) of Regulation (EC) No 883/2004 must be interpreted as precluding conditions such as

(i)

that the benefit may be provided only for a maximum of four weeks per year outside of Norway;

| (ii) | that it must be demonstrated that the stay abroad is compatible with the activity obligations and does not impede follow-up and control by the competent institution; and |
| --- | --- |

(ii)

that it must be demonstrated that the stay abroad is compatible with the activity obligations and does not impede follow-up and control by the competent institution; and

| (iii) | that the person concerned must obtain authorisation and comply with the notification duty through the use of a notification form. |
| --- | --- |

(iii)

that the person concerned must obtain authorisation and comply with the notification duty through the use of a notification form.

Accordingly, a further assessment of such conditions under other provisions of EEA law is not necessary.

| 8. | Having regard to the answer given to the fifteenth question, as well as the fifth, sixth, seventh and eighth questions, it is not necessary to answer the sixteenth question. |
| --- | --- |

8.

Having regard to the answer given to the fifteenth question, as well as the fifth, sixth, seventh and eighth questions, it is not necessary to answer the sixteenth question.

---

OTHER ACTS

European Commission

| 12.8.2021 | EN | Official Journal of the European Union | C 324/33 |
| --- | --- | --- | --- |

12.8.2021

EN

Official Journal of the European Union

C 324/33

---

Publication of a communication of approval of a standard amendment to a product specification for a name in the wine sector referred to in Article 17(2) and (3) of Commission Delegated Regulation (EU) 2019/33

(2021/C 324/13)

This communication is published in accordance with Article 17(5) of Commission Delegated Regulation (EU) 2019/33 (1).

COMMUNICATION OF A STANDARD AMENDMENT TO THE SINGLE DOCUMENT

‘Morgon’

PDO-FR-A1024-AM02

Date of communication: 4 June 2021

DESCRIPTION OF AND REASONS FOR THE APPROVED AMENDMENT

1.   Geographical area

In chapter I, section IV, point 1, the words ‘based on the 2019 Official Geographical Code’ have been added after ‘Rhône’.

This editorial amendment allows the geographical area to be identified with reference to the 2019 version of the Official Geographical Code, which is updated by the National Institute of Statistics and Economic Studies (INSEE), and gives the definition of the geographical area legal certainty.

The boundaries of the geographical area remain unchanged.

The phrase ‘are undertaken’ has been replaced by ‘take place’.

Point 6 of the single document has been amended to include these changes.

A sentence has also been added with the information that cartographic documents pertaining to the geographical area are available on the INAO website.

The single document is not affected by this amendment.

2.   Area in immediate proximity

In chapter I, section IV, point 3, the words ‘based on the 2019 Official Geographical Code’ have been added after ‘the following municipalities’.

A reference to the 2019 Official Geographical Code has been added and the list of municipalities updated. The date of approval of the geographical area of the designation by the competent national committee of the National Institute of Origin and Quality has also been added. These amendments change the wording but do not have any effect on the boundary of the geographical area in question. They are necessary as a result of mergers and splits among municipalities, or parts of municipalities, or name changes.

The new wording ensures that the municipalities in the geographical area continue to be clearly identified in the specification.

The section of the single document headed ‘Further conditions’ has been amended accordingly.

3.   Provisions relating to maturation

In chapter I, section IX, point 2, ‘1 March’ has been replaced by ‘15 January’.

The end date of the minimum maturation period for the wines has been brought forward from 1 March to 15 January of the year following that of the harvest. This is due to early harvests becoming more common as a result of climate change, thus allowing earlier completion of the wine-making process.

Bringing forward the end date of the minimum maturation period does not affect the quality of the wines with the designation. The soils of the municipality of Villié-Morgon have formed on a variety of substrates, some of which produce fruity wines that are already pleasant when young.

Point 5 of the single document has been amended. Wine-making practices

4.   Placing on the market for sale to consumers

In chapter I, section IX, point 5, ‘15 March’ has been replaced by ‘1 February’.

As the end date of the minimum maturation period has been brought forward, the date for placing the wines on the market for sale to consumers has also been brought forward, from 15 March to 1 February.

This amendment does not require any changes to the single document.

5.   Transport between authorised warehouses

Point 5(b), section IX, chapter I, concerning the date from which the wines can transported between authorised warehouses, has been deleted.

The minimum maturation period has been reduced and the date on which wines are placed on the market has been brought forward. It is therefore necessary to allow the wines to be transported between operators sooner. There is no need to establish an earlier date before which the wines cannot be transported.

The title of point 5, section IX, chapter I has therefore been amended, with the removal of the words ‘the transport of products and’.

The single document is not affected by these amendments to the specification.

6.   Transitional measures

In chapter I, section XI, point 1(a), the phrase ‘at the latest’ has been added before the words ‘up to and including the 2034 harvest’, in order to be more specific about the conditions for this measure.

Point 3 has been deleted as the specific measures have expired.

The single document is not affected by these amendments to the specification.

7.   Matters concerning monitoring the specification

- Operators are now monitored by a certification body. The words ‘inspection plans’ have been replaced by the words ‘monitoring plan’ in the relevant paragraphs in chapter II of the specification.

The single document is not affected by this amendment.

- References to the inspection body

In section II of chapter III: the rules on wording in this section have been amended since approval of the specification in December 2011. The purpose was to remove full references to the inspection authority where monitoring is conducted by a certification body.

The single document is not affected by this amendment.

SINGLE DOCUMENT

1.   Name(s)

Morgon

2.   Geographical indication type

PDO – Protected Designation of Origin

3.   Categories of grapevine products

| 1. | Wine |
| --- | --- |

1.

4.   Description of the wine(s)

Brief written description

The wines are still, dry red wines. The wines have a minimum natural alcoholic strength by volume of 10,5 %.

The total alcoholic strength by volume of the wines after enrichment does not exceed 13 %.

At the time of packaging, the wines have a maximum malic acid content of 0,4 grams per litre.

Wines that are finished and ready to be released for consumption conform to the following analytical standards:

Maximum fermentable sugar content (glucose and fructose): 3 grams per litre

The standards provided for in EU regulations apply to the maximum total alcoholic strength, minimum actual alcoholic strength, minimum total acidity and maximum total sulphur dioxide content.

The wines combine the fruitiness of the wines of the Beaujolais region with body, plenty of minerality and aromas that often evoke raspberry and kirsch. The wines are particularly suitable for ageing, during which time they develop unique and complex aromas. Devotees are often able to distinguish between parcels with soils formed on granitic sand, which produce wines that are fruity and already pleasant when young, and parcels with soils formed on schist, which produce more austere wines that benefit from being kept for several years.

General analytical characteristics

| General analytical characteristics |
| --- |
| Maximum total alcoholic strength (in % volume) | |
| Minimum actual alcoholic strength (in % volume) | |
| Minimum total acidity | |
| Maximum volatile acidity (in milliequivalents per litre) | 14,17 |
| Maximum total sulphur dioxide (in milligrams per litre) | |

General analytical characteristics

Maximum total alcoholic strength (in % volume)

Minimum actual alcoholic strength (in % volume)

Minimum total acidity

Maximum volatile acidity (in milliequivalents per litre)

14,17

Maximum total sulphur dioxide (in milligrams per litre)

5.   Wine-making practices

5.1.   Specific oenological practices

1.   Specific oenological practice

| — | The use of wood chips is not permitted. |
| --- | --- |

—

The use of wood chips is not permitted.

| — | The total alcoholic strength by volume of the wines after enrichment does not exceed 13 %. |
| --- | --- |

—

The total alcoholic strength by volume of the wines after enrichment does not exceed 13 %.

| — | Subtractive enrichment techniques are permitted up to a concentration rate of 10 %. |
| --- | --- |

—

Subtractive enrichment techniques are permitted up to a concentration rate of 10 %.

| — | The wines must be aged until at least 15 January of the year following the harvest. |
| --- | --- |

—

The wines must be aged until at least 15 January of the year following the harvest.

In addition to the above provisions, all wine-making practices followed must also comply with the requirements laid down at EU level and in the Rural and Maritime Fishing Code.

2.   Cultivation method

| — | Planting density
  The minimum vine planting density is 6 000 plants per hectare.
  The spacing between the rows is 2,10 metres or less. Between plants in the same row, spacing is at least 0,80 metres.
  Provided that the minimum density of 6 000 plants per hectare is maintained, for the purposes of mechanisation, the spaces between rows may be a maximum of 3 metres. |
| --- | --- |

—

Planting density

The minimum vine planting density is 6 000 plants per hectare.

The spacing between the rows is 2,10 metres or less. Between plants in the same row, spacing is at least 0,80 metres.

Provided that the minimum density of 6 000 plants per hectare is maintained, for the purposes of mechanisation, the spaces between rows may be a maximum of 3 metres.

| — | Pruning rules






  — | Pruning is completed by 15 May. |
| --- | --- | --- |

—

Pruning rules

—

Pruning is completed by 15 May.

| — | The wines are made from vines subject to spur pruning and trained to gobelet, éventail, single or double cordon de Royat, or ‘Charmet’. Each plant has a maximum of ten buds. |
| --- | --- |

—

The wines are made from vines subject to spur pruning and trained to gobelet, éventail, single or double cordon de Royat, or ‘Charmet’. Each plant has a maximum of ten buds.

| — | Each plant has three to five spurs with a maximum of two buds. For regeneration purposes, each plant may also have a spur with a maximum of two buds cut from a water shoot growing out of the permanent wood. |
| --- | --- |

—

Each plant has three to five spurs with a maximum of two buds. For regeneration purposes, each plant may also have a spur with a maximum of two buds cut from a water shoot growing out of the permanent wood.

| — | During initial pruning, or conversion to a different form of pruning, vines are pruned to a maximum of 12 buds per plant. |
| --- | --- |

—

During initial pruning, or conversion to a different form of pruning, vines are pruned to a maximum of 12 buds per plant.

Irrigation is prohibited.

| — | Provisions relating to mechanised harvesting






  — | The harvest is piled no higher than 0.50 metres high in the containers transporting it from the parcel to the winery. |
| --- | --- | --- |

—

Provisions relating to mechanised harvesting

—

The harvest is piled no higher than 0.50 metres high in the containers transporting it from the parcel to the winery.

| — | The containers are made of inert material suitable for food-use. |
| --- | --- |

—

The containers are made of inert material suitable for food-use.

| — | The equipment for picking and transporting the harvest includes a special water-drainage or protection system. |
| --- | --- |

—

The equipment for picking and transporting the harvest includes a special water-drainage or protection system.

5.2.   Maximum yields

| 1. | 61 hectolitres per hectare |
| --- | --- |

1.

61 hectolitres per hectare

6.   Demarcated geographical area

The grapes are harvested and the wines are produced, developed and aged in the following municipality of the Rhône department, based on the 2019 Official Geographic Code: Villié-Morgon.

7.   Main wine grape variety(-ies)

Gamay N

8.   Description of the link(s)

8.1.   Description of the natural factors relevant to the link

The geographical area extends over the eastern sides of the Beaujolais hills, specifically on the lower slopes of the Fût d’Avenas hill, which has a summit of 842 metres in altitude.

Located to the north of the department of Rhône, it is entirely within the municipality of Villié-Morgon, 19 kilometres north of Villefranche-sur-Saône, and 21 kilometres south of Mâcon.

The geographical area offers an undulating landscape with slopes becoming steeper to the west. These elevations were carved out by streams such as the Morcille, a tributary of the Ardières, and the Douby, which both empty into the Saône. The hillsides range in altitude from 220 to 480 metres. They are south-east facing and look out over the broad Saône plain.

The substrate of the geographical area includes three major types of formation:

| — | manganese-rich schist, dating from the Upper Devonian; on disintegrating the rock produces clay soils known locally as ‘morgon’; this formation is present in the centre and east, and especially on the Py hill; |
| --- | --- |

—

manganese-rich schist, dating from the Upper Devonian; on disintegrating the rock produces clay soils known locally as ‘morgon’; this formation is present in the centre and east, and especially on the Py hill;

| — | porphyritic granite producing, by alteration, sandy areas that result in poor soils with filtering qualities, to the north and north-west; |
| --- | --- |

—

porphyritic granite producing, by alteration, sandy areas that result in poor soils with filtering qualities, to the north and north-west;

| — | on the eastern side, the lower slopes lie under colluvium and ancient river terraces of the Quaternary age; the soils are therefore varied, in places very sandy and elsewhere rich in clay. |
| --- | --- |

—

on the eastern side, the lower slopes lie under colluvium and ancient river terraces of the Quaternary age; the soils are therefore varied, in places very sandy and elsewhere rich in clay.

The climate is maritime, subject to continental and southern influences. Rainfall is evenly distributed throughout the year, and the average annual temperature is close to 11 °C. The Beaujolais hills play a vital role providing protection from the west winds, thereby diminishing the maritime influence. The hills produce a foehn effect that dries the damp air, enhancing the light and reducing rainfall correspondingly.

The broad Saône valley also plays a significant role in the development of the vines. It ensures abundant light, around 2 000 hours a year on average, and channels southern influences, characterised in particular by intense heat in summer.

8.2.   Description of the human factors relevant to the link

Evidence of vines in Villié-Morgon in the year 956 is provided by a document recording the sale of a parcel by the Lord of Beaujeu to a vassal.

From the end of the 15th century, having grown rich from silk and banking, the bourgeoisie of Lyon developed vineyards.

Highly reputed and prized, the wines of ‘Morgon’ were recognised with a controlled designation of origin by the Decree of 11 September 1936.

The controlled designation of origin ‘Morgon’ represents a fusion of characteristic regional traditions with modern techniques.

In pursuit of quality wines, the producers have learned to tame the gamay N variety and its growth, notably by using high planting density and spur pruning.

In order for the grapes to ripen properly, producers ensure that the canopy is sufficiently open. In this way, the vines can be trained on fixed trellising.

In line with current practice, producers have adopted a particular wine-making method involving both traditional fermentation and semi-carbonic maceration.

In 2010, the vineyards of ‘Morgon’ covered an area of over 1 100 hectares, with an average annual production of 55 000 hectolitres, made by 451 producers who sell more than 40 % of their wines directly.

8.3.   Causal interactions

The position of the vineyards on the hillsides, overlooking the broad Saône plain, allows them to benefit from favourable climate conditions. While the aspect is south-east facing, the microrelief favours all aspects and ensures optimal sunshine.

Located some 10 kilometres from the Saône, the vineyards benefit from the thermally moderating influence of the valley. However, they are sufficiently far away not to suffer the negative aspects such as freezing fog and late spring frosts.

The soils of the municipality of Villié-Morgon have formed on diverse substrates. They offer a certain variety with sandy areas on granite, heavier clay on schist, and relatively deep soils with filtering qualities on the colluvium and ancient terraces. This feature is fundamental for the unique nature of the wines. The gamay N grape variety expresses all these subtleties in the wines. The wines from parcels with soils formed on schist have a unique characteristic which producers describe with the verb morgonner (to ‘morgon’). The finest, and most famous, example is the wine from the parcels located on the Py hill.

Down the generations, producers have adopted and improved the most appropriate techniques for the gamay N variety, focusing on the very best expression of the subtleties created by the substrates. In addition, and according to custom, they are in the habit of stating the name of the lieudit, or plot, that provided the grapes.

In the 19th century, in his work Topographie de tous les vignobles connus (Topography of all known vineyards), Jullien states: ‘Morgon, a hamlet situated on the steep mountain in the municipality of Villiers, in its finest production provides robust and lively wines with good taste. They keep for a long time and the result is always good’.

In 1953, the producers set up the first and largest tasting centre of the region in the Château de Fontcrenne. A veritable temple, its various rooms host the ceremonies and soirées that are part of life for the controlled designation of origin.

9.   Essential further conditions (packaging, labelling, other requirements)

Area in immediate proximity

Legal framework

National legislation

Type of further condition

Derogation concerning production in the demarcated geographical area

Description of the condition

The area in the immediate vicinity, defined by derogation for wine-making, maturing and ageing comprises the territory of the following municipalities, based on the Official Geographic Code for 2019:

| — | Department of Côte-d’Or:
  Agencourt, Aloxe-Corton, Ancey, Arcenant, Argilly, Autricourt, Auxey-Duresses, Baubigny, Beaune, Belan-sur-Ource, Bévy, Bissey-la-Côte, Bligny-lès-Beaune, Boncourt-le-Bois, Bouix, Bouze-lès-Beaune, Brion-sur-Ource, Brochon, Cérilly, Chamboeuf, Chambolle-Musigny, Channay, Charrey-sur-Seine, Chassagne-Montrachet, Châtillon-sur-Seine, Chaumont-le-Bois, Chaux, Chenôve, Chevannes, Chorey-lès-Beaune, Clémencey, Collonges-lès-Bévy, Combertault, Comblanchien, Corcelles-les-Arts, Corcelles-les-Monts, Corgoloin, Cormot-Vauchignon, Corpeau, Couchey, Curley, Curtil-Vergy, Daix, Dijon, Ebaty, Echevronne, Epernay-sous-Gevrey, L’Etang-Vergy, Etrochey, Fixin, Flagey-Echézeaux, Flavignerot, Fleurey-sur-Ouche, Fussey, Gerland, Gevrey-Chambertin, Gilly-lès-Cîteaux, Gomméville, Grancey-sur-Ource, Griselles, Ladoix-Serrigny, Lantenay, Larrey, Levernois, Magny-lès-Villers, Mâlain, Marcenay, Marey-lès-Fussey, Marsannay-la-Côte, Massingy, Mavilly-Mandelot, Meloisey, Merceuil, Messanges, Meuilley, Meursanges, Meursault, Molesme, Montagny-lès-Beaune, Monthelie, Montliot-et-Courcelles, Morey-Saint-Denis, Mosson, Nantoux, Nicey, Noiron-sur-Seine, Nolay, Nuits-Saint-Georges, Obtrée, Pernand-Vergelesses, Perrigny-lès-Dijon, Plombières-lès-Dijon, Poinçon-lès-Larrey, Pommard, Pothières, Premeaux-Prissey, Prusly-sur-Ource, Puligny-Montrachet, Quincey, Reulle-Vergy, La Rochepot, Ruffey-lès-Beaune, Saint-Aubin, Saint-Bernard, Saint-Philibert, Saint-Romain, Sainte-Colombe-sur-Seine, Sainte-Marie-la-Blanche, Santenay, Savigny-lès-Beaune, Segrois, Tailly, Talant, Thoires, Vannaire, Velars-sur-Ouche, Vertault, Vignoles, Villars-Fontaine, Villebichot, Villedieu, Villers-la-Faye, Villers-Patras, Villy-le-Moutier, Vix, Volnay, Vosne-Romanée and Vougeot |
| --- | --- |

—

Department of Côte-d’Or:

Agencourt, Aloxe-Corton, Ancey, Arcenant, Argilly, Autricourt, Auxey-Duresses, Baubigny, Beaune, Belan-sur-Ource, Bévy, Bissey-la-Côte, Bligny-lès-Beaune, Boncourt-le-Bois, Bouix, Bouze-lès-Beaune, Brion-sur-Ource, Brochon, Cérilly, Chamboeuf, Chambolle-Musigny, Channay, Charrey-sur-Seine, Chassagne-Montrachet, Châtillon-sur-Seine, Chaumont-le-Bois, Chaux, Chenôve, Chevannes, Chorey-lès-Beaune, Clémencey, Collonges-lès-Bévy, Combertault, Comblanchien, Corcelles-les-Arts, Corcelles-les-Monts, Corgoloin, Cormot-Vauchignon, Corpeau, Couchey, Curley, Curtil-Vergy, Daix, Dijon, Ebaty, Echevronne, Epernay-sous-Gevrey, L’Etang-Vergy, Etrochey, Fixin, Flagey-Echézeaux, Flavignerot, Fleurey-sur-Ouche, Fussey, Gerland, Gevrey-Chambertin, Gilly-lès-Cîteaux, Gomméville, Grancey-sur-Ource, Griselles, Ladoix-Serrigny, Lantenay, Larrey, Levernois, Magny-lès-Villers, Mâlain, Marcenay, Marey-lès-Fussey, Marsannay-la-Côte, Massingy, Mavilly-Mandelot, Meloisey, Merceuil, Messanges, Meuilley, Meursanges, Meursault, Molesme, Montagny-lès-Beaune, Monthelie, Montliot-et-Courcelles, Morey-Saint-Denis, Mosson, Nantoux, Nicey, Noiron-sur-Seine, Nolay, Nuits-Saint-Georges, Obtrée, Pernand-Vergelesses, Perrigny-lès-Dijon, Plombières-lès-Dijon, Poinçon-lès-Larrey, Pommard, Pothières, Premeaux-Prissey, Prusly-sur-Ource, Puligny-Montrachet, Quincey, Reulle-Vergy, La Rochepot, Ruffey-lès-Beaune, Saint-Aubin, Saint-Bernard, Saint-Philibert, Saint-Romain, Sainte-Colombe-sur-Seine, Sainte-Marie-la-Blanche, Santenay, Savigny-lès-Beaune, Segrois, Tailly, Talant, Thoires, Vannaire, Velars-sur-Ouche, Vertault, Vignoles, Villars-Fontaine, Villebichot, Villedieu, Villers-la-Faye, Villers-Patras, Villy-le-Moutier, Vix, Volnay, Vosne-Romanée and Vougeot

| — | Department of Rhône:
  Alix, Anse, L’Arbresle, Les Ardillats, Arnas, Bagnols, Beaujeu, Belleville-en-Beaujolais, Belmont-d’Azergues, Blacé, Le Breuil, Bully, Chambost-Allières, Chamelet, Charentay, Charnay, Chasselay, Châtillon, Chazay-d’Azergues, Chénas, Chessy, Chiroubles, Cogny, Corcelles-en-Beaujolais, Dardilly, Denicé, Deux Grosnes (only the part in the territory of the former municipality of Avenas), Dracé, Emeringes, Fleurie, Fleurieux-sur-l’Arbresle, Frontenas, Gleizé, Juliénas, Jullié, Lacenas, Lachassagne, Lancié, Lantignié, Légny, Létra, Limas, Lozanne, Lucenay, Marchampt, Marcy, Moiré, Montmelas-Saint-Sorlin, Morancé, Odenas, Le Perréon, Pommiers, Porte des Pierres Dorées, Quincié-en-Beaujolais, Régnié-Durette, Rivolet, Sain-Bel, Saint-Clément-sur-Valsonne, Saint-Cyr-le-Chatoux, Saint-Didier-sur-Beaujeu, Saint-Etienne-des-Oullières, Saint-Etienne-la-Varenne, Saint-Georges-de-Reneins, Saint-Germain-Nuelles, Saint-Jean-des-Vignes, Saint-Julien, Saint-Just-d’Avray, Saint-Lager, Saint-Romain-de-Popey, Saint-Vérand, Sainte-Paule, Salles-Arbuissonnas-en-Beaujolais, Sarcey, Taponas, Ternand, Theizé, Val d’Oingt, Vaux-en-Beaujolais, Vauxrenard, Vernay, Villefranche-sur-Saône, Ville-sur-Jarnioux and Vindry-sur-Turdine (only the part in the territory of the former municipalities of Dareizé, Les Olmes and Saint-Loup) |
| --- | --- |

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Department of Rhône:

Alix, Anse, L’Arbresle, Les Ardillats, Arnas, Bagnols, Beaujeu, Belleville-en-Beaujolais, Belmont-d’Azergues, Blacé, Le Breuil, Bully, Chambost-Allières, Chamelet, Charentay, Charnay, Chasselay, Châtillon, Chazay-d’Azergues, Chénas, Chessy, Chiroubles, Cogny, Corcelles-en-Beaujolais, Dardilly, Denicé, Deux Grosnes (only the part in the territory of the former municipality of Avenas), Dracé, Emeringes, Fleurie, Fleurieux-sur-l’Arbresle, Frontenas, Gleizé, Juliénas, Jullié, Lacenas, Lachassagne, Lancié, Lantignié, Légny, Létra, Limas, Lozanne, Lucenay, Marchampt, Marcy, Moiré, Montmelas-Saint-Sorlin, Morancé, Odenas, Le Perréon, Pommiers, Porte des Pierres Dorées, Quincié-en-Beaujolais, Régnié-Durette, Rivolet, Sain-Bel, Saint-Clément-sur-Valsonne, Saint-Cyr-le-Chatoux, Saint-Didier-sur-Beaujeu, Saint-Etienne-des-Oullières, Saint-Etienne-la-Varenne, Saint-Georges-de-Reneins, Saint-Germain-Nuelles, Saint-Jean-des-Vignes, Saint-Julien, Saint-Just-d’Avray, Saint-Lager, Saint-Romain-de-Popey, Saint-Vérand, Sainte-Paule, Salles-Arbuissonnas-en-Beaujolais, Sarcey, Taponas, Ternand, Theizé, Val d’Oingt, Vaux-en-Beaujolais, Vauxrenard, Vernay, Villefranche-sur-Saône, Ville-sur-Jarnioux and Vindry-sur-Turdine (only the part in the territory of the former municipalities of Dareizé, Les Olmes and Saint-Loup)

| — | Department of Saône-et-Loire:
  Aluze, Ameugny, Azé, Barizey, Beaumont-sur-Grosne, Berzé-la-Ville, Berzé-le-Châtel, Bissey-sous-Cruchaud, Bissy-la-Mâconnaise, Bissy-sous-Uxelles, Bissy-sur-Fley, Blanot, Bonnay, Bouzeron, Boyer, Bray, Bresse-sur-Grosne, Burgy, Burnand, Bussières, Buxy, Cersot, Chagny, Chaintré, Chalon-sur-Saône, Chamilly, Champagny-sous-Uxelles, Champforgeuil, Chânes, Change, Chapaize, La Chapelle-de-Bragny, La Chapelle-de-Guinchay, La Chapelle-sous-Brancion, Charbonnières, Chardonnay, La Charmée, Charnay-lès-Mâcon, Charrecey, Chasselas, Chassey-le-Camp, Château, Châtenoy-le-Royal, Chaudenay, Cheilly-lès-Maranges, Chenôves, Chevagny-les-Chevrières, Chissey-lès-Mâcon, Clessé, Cluny, Cormatin, Cortambert, Cortevaix, Couches, Crêches-sur-Saône, Créot, Cruzille, Culles-les-Roches, Curtil-sous-Burnand, Davayé, Demigny, Dennevy, Dezize-lès-Maranges, Donzy-le-Pertuis, Dracy-le-Fort, Dracy-lès-Couches, Epertully, Etrigny, Farges-lès-Chalon, Farges-lès-Mâcon, Flagy, Fleurville, Fley, Fontaines, Fragnes-La-Loyère (only the part in the territory of the former municipality of La Loyère), Fuissé, Genouilly, Germagny, Givry, Granges, Grevilly, Hurigny, Igé, Jalogny, Jambles, Jugy, Jully-lès-Buxy, Lacrost, Laives, Laizé, Lalheue, Leynes, Lournand, Lugny, Mâcon, Malay, Mancey, Martailly-lès-Brancion, Massilly, Mellecey, Mercurey, Messey-sur-Grosne, Milly-Lamartine, Montagny-lès-Buxy, Montbellet, Montceaux-Ragny, Moroges, Nanton, Ozenay, Paris-l’Hôpital, Péronne, Pierreclos, Plottes, Préty, Prissé, Pruzilly, Remigny, La Roche-Vineuse, Romanèche-Thorins, Rosey, Royer, Rully, Saint-Albain, Saint-Ambreuil, Saint-Amour-Bellevue, Saint-Boil, Saint-Clément-sur-Guye, Saint-Denis-de-Vaux, Saint-Désert, Saint-Gengoux-de-Scissé, Saint-Gengoux-le-National, Saint-Germain-lès-Buxy, Saint-Gervais-sur-Couches, Saint-Gilles, Saint-Jean-de-Trézy, Saint-Jean-de-Vaux, Saint-Léger-sur-Dheune, Saint-Mard-de-Vaux, Saint-Martin-Belle-Roche, Saint-Martin-du-Tartre, Saint-Martin-sous-Montaigu, Saint-Maurice-de-Satonnay, Saint-Maurice-des-Champs, Saint-Maurice-lès-Couches, Saint-Pierre-de-Varennes, Saint-Rémy, Saint-Sernin-du-Plain, Saint-Symphorien-d’Ancelles, Saint-Vallerin, Saint-Vérand, Saint-Ythaire, Saisy, La Salle, Salornay-sur-Guye, Sampigny-lès-Maranges, Sancé, Santilly, Sassangy, Saules, Savigny-sur-Grosne, Sennecey-le-Grand, Senozan, Sercy, Serrières, Sigy-le-Châtel, Sologny, Solutré-Pouilly, Taizé, Tournus, Uchizy, Varennes-lès-Mâcon, Vaux-en-Pré, Vergisson, Vers, Verzé, Le Villars, La Vineuse sur Fregande (only the part in the territory of the former municipalities of Donzy-le-National, Massy et La Vineuse), Vinzelles and Viré |
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Department of Saône-et-Loire:

Aluze, Ameugny, Azé, Barizey, Beaumont-sur-Grosne, Berzé-la-Ville, Berzé-le-Châtel, Bissey-sous-Cruchaud, Bissy-la-Mâconnaise, Bissy-sous-Uxelles, Bissy-sur-Fley, Blanot, Bonnay, Bouzeron, Boyer, Bray, Bresse-sur-Grosne, Burgy, Burnand, Bussières, Buxy, Cersot, Chagny, Chaintré, Chalon-sur-Saône, Chamilly, Champagny-sous-Uxelles, Champforgeuil, Chânes, Change, Chapaize, La Chapelle-de-Bragny, La Chapelle-de-Guinchay, La Chapelle-sous-Brancion, Charbonnières, Chardonnay, La Charmée, Charnay-lès-Mâcon, Charrecey, Chasselas, Chassey-le-Camp, Château, Châtenoy-le-Royal, Chaudenay, Cheilly-lès-Maranges, Chenôves, Chevagny-les-Chevrières, Chissey-lès-Mâcon, Clessé, Cluny, Cormatin, Cortambert, Cortevaix, Couches, Crêches-sur-Saône, Créot, Cruzille, Culles-les-Roches, Curtil-sous-Burnand, Davayé, Demigny, Dennevy, Dezize-lès-Maranges, Donzy-le-Pertuis, Dracy-le-Fort, Dracy-lès-Couches, Epertully, Etrigny, Farges-lès-Chalon, Farges-lès-Mâcon, Flagy, Fleurville, Fley, Fontaines, Fragnes-La-Loyère (only the part in the territory of the former municipality of La Loyère), Fuissé, Genouilly, Germagny, Givry, Granges, Grevilly, Hurigny, Igé, Jalogny, Jambles, Jugy, Jully-lès-Buxy, Lacrost, Laives, Laizé, Lalheue, Leynes, Lournand, Lugny, Mâcon, Malay, Mancey, Martailly-lès-Brancion, Massilly, Mellecey, Mercurey, Messey-sur-Grosne, Milly-Lamartine, Montagny-lès-Buxy, Montbellet, Montceaux-Ragny, Moroges, Nanton, Ozenay, Paris-l’Hôpital, Péronne, Pierreclos, Plottes, Préty, Prissé, Pruzilly, Remigny, La Roche-Vineuse, Romanèche-Thorins, Rosey, Royer, Rully, Saint-Albain, Saint-Ambreuil, Saint-Amour-Bellevue, Saint-Boil, Saint-Clément-sur-Guye, Saint-Denis-de-Vaux, Saint-Désert, Saint-Gengoux-de-Scissé, Saint-Gengoux-le-National, Saint-Germain-lès-Buxy, Saint-Gervais-sur-Couches, Saint-Gilles, Saint-Jean-de-Trézy, Saint-Jean-de-Vaux, Saint-Léger-sur-Dheune, Saint-Mard-de-Vaux, Saint-Martin-Belle-Roche, Saint-Martin-du-Tartre, Saint-Martin-sous-Montaigu, Saint-Maurice-de-Satonnay, Saint-Maurice-des-Champs, Saint-Maurice-lès-Couches, Saint-Pierre-de-Varennes, Saint-Rémy, Saint-Sernin-du-Plain, Saint-Symphorien-d’Ancelles, Saint-Vallerin, Saint-Vérand, Saint-Ythaire, Saisy, La Salle, Salornay-sur-Guye, Sampigny-lès-Maranges, Sancé, Santilly, Sassangy, Saules, Savigny-sur-Grosne, Sennecey-le-Grand, Senozan, Sercy, Serrières, Sigy-le-Châtel, Sologny, Solutré-Pouilly, Taizé, Tournus, Uchizy, Varennes-lès-Mâcon, Vaux-en-Pré, Vergisson, Vers, Verzé, Le Villars, La Vineuse sur Fregande (only the part in the territory of the former municipalities of Donzy-le-National, Massy et La Vineuse), Vinzelles and Viré

| — | Department of Yonne:
  Aigremont, Annay-sur-Serein, Arcy-sur-Cure, Asquins, Augy, Auxerre, Avallon, Bazarnes, Beine, Bernouil, Béru, Bessy-sur-Cure, Bleigny-le-Carreau, Censy, Chablis, Champlay, Champs-sur-Yonne, Chamvres, La Chapelle-Vaupelteigne, Charentenay, Châtel-Gérard, Chemilly-sur-Serein, Cheney, Chevannes, Chichée, Chitry, Collan, Coulangeron, Coulanges-la-Vineuse, Courgis, Cruzy-le-Châtel, Dannemoine, Deux Rivières, Dyé, Epineuil, Escamps, Escolives-Sainte-Camille, Fleys, Fontenay-près-Chablis, Gy-l’Evêque, Héry, Irancy, Island, Joigny, Jouancy, Junay, Jussy, Lichères-près-Aigremont, Lignorelles, Ligny-le-Châtel, Lucy-sur-Cure, Maligny, Mélisey, Merry-Sec, Migé, Molay, Molosmes, Montigny-la-Resle, Montholon (only the part in the territory of the former municipalities of Champvallon, Villiers sur Tholon and Volgré), Mouffy, Moulins-en-Tonnerrois, Nitry, Noyers, Ouanne, Paroy-sur-Tholon, Pasilly, Pierre-Perthuis, Poilly-sur-Serein, Pontigny, Préhy, Quenne, Roffey, Rouvray, Saint-Bris-le-Vineux, Saint-Cyr-les-Colons, Saint-Père, Sainte-Pallaye, Sainte-Vertu, Sarry, Senan, Serrigny, Tharoiseau, Tissey, Tonnerre, Tronchoy, Val-de-Mercy, Vallan, Venouse, Venoy, Vermenton, Vézannes, Vézelay, Vézinnes, Villeneuve-Saint-Salves, Villy, Vincelles, Vincelottes, Viviers and Yrouerre. |
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Department of Yonne:

Aigremont, Annay-sur-Serein, Arcy-sur-Cure, Asquins, Augy, Auxerre, Avallon, Bazarnes, Beine, Bernouil, Béru, Bessy-sur-Cure, Bleigny-le-Carreau, Censy, Chablis, Champlay, Champs-sur-Yonne, Chamvres, La Chapelle-Vaupelteigne, Charentenay, Châtel-Gérard, Chemilly-sur-Serein, Cheney, Chevannes, Chichée, Chitry, Collan, Coulangeron, Coulanges-la-Vineuse, Courgis, Cruzy-le-Châtel, Dannemoine, Deux Rivières, Dyé, Epineuil, Escamps, Escolives-Sainte-Camille, Fleys, Fontenay-près-Chablis, Gy-l’Evêque, Héry, Irancy, Island, Joigny, Jouancy, Junay, Jussy, Lichères-près-Aigremont, Lignorelles, Ligny-le-Châtel, Lucy-sur-Cure, Maligny, Mélisey, Merry-Sec, Migé, Molay, Molosmes, Montigny-la-Resle, Montholon (only the part in the territory of the former municipalities of Champvallon, Villiers sur Tholon and Volgré), Mouffy, Moulins-en-Tonnerrois, Nitry, Noyers, Ouanne, Paroy-sur-Tholon, Pasilly, Pierre-Perthuis, Poilly-sur-Serein, Pontigny, Préhy, Quenne, Roffey, Rouvray, Saint-Bris-le-Vineux, Saint-Cyr-les-Colons, Saint-Père, Sainte-Pallaye, Sainte-Vertu, Sarry, Senan, Serrigny, Tharoiseau, Tissey, Tonnerre, Tronchoy, Val-de-Mercy, Vallan, Venouse, Venoy, Vermenton, Vézannes, Vézelay, Vézinnes, Villeneuve-Saint-Salves, Villy, Vincelles, Vincelottes, Viviers and Yrouerre.

Labelling

Legal framework

National legislation

Type of further condition

Additional provisions relating to labelling

Description of the condition

| a) | Wines with the registered designation of origin may specify on their labels the name of a smaller geographical unit, provided that:






  — | it is the name of a place in the land register; |
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a)

Wines with the registered designation of origin may specify on their labels the name of a smaller geographical unit, provided that:

—

it is the name of a place in the land register;

| — | it appears on the harvest declaration. |
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it appears on the harvest declaration.

The name of the registered location appears immediately after the controlled designation of origin, and is printed in lettering no greater in both height and width than the letters in which the name of the controlled designation of origin is written.

| b) | The labels of wines entitled to the controlled designation of origin can mention the larger geographical entity ‘Vin du Beaujolais’, ‘Grand Vin du Beaujolais’ or ‘Cru du Beaujolais’.
  The size of the letters for the broader geographical unit must not be larger, either in height or width, than two-thirds of the size of the letters forming the name of the controlled designation of origin. |
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b)

The labels of wines entitled to the controlled designation of origin can mention the larger geographical entity ‘Vin du Beaujolais’, ‘Grand Vin du Beaujolais’ or ‘Cru du Beaujolais’.

The size of the letters for the broader geographical unit must not be larger, either in height or width, than two-thirds of the size of the letters forming the name of the controlled designation of origin.

Link to the product specification

https://info.agriculture.gouv.fr/gedei/site/bo-agri/document_administratif-1169e922-4ee5-4592-8f0f-27a337e58a43

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(1)  OJ L 9, 11.1.2019, p. 2.

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