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Document C:2020:308:FULL

Official Journal of the European Union, C 308, 17 September 2020


Display all documents published in this Official Journal
 

ISSN 1977-091X

Official Journal

of the European Union

C 308

European flag  

English edition

Information and Notices

Volume 63
17 September 2020


Contents

page

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

 

European Commission

2020/C 308/01

Euro exchange rates — 16 September 2020

1

2020/C 308/02

Notice pursuant to Article 6(6)(f) of Protocol II concerning the definition of the concept of originating products and methods of administrative cooperation under the Interim Partnership Agreement between the European Community, of the one part and the Pacific States, of the other part

2

 

Court of Auditors

2020/C 308/03

Special Report 18/2020 The EU’s Emissions Trading System: free allocation of allowances needed better targeting

3

 

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

 

Standing Committee of the EFTA States

2020/C 308/04

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 2019 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee

4

2020/C 308/05

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 2019 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee

6

2020/C 308/06

Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2019 Subcommittee I on the free movement of goods To be noted by the EEA Joint Committee

9


 

V   Announcements

 

COURT PROCEEDINGS

 

EFTA Court

2020/C 308/07

Request for an Advisory Opinion from the EFTA Court by Borgarting Lagmannsrett dated 11 May 2020 in the case of Tor-Arne Martinez Haugland v The Norwegian Government (Case E-4/20)

21

 

OTHER ACTS

 

European Commission

2020/C 308/08

Publication of an application for registration of a name pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

22


EN

 


IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

17.9.2020   

EN

Official Journal of the European Union

C 308/1


Euro exchange rates (1)

16 September 2020

(2020/C 308/01)

1 euro =


 

Currency

Exchange rate

USD

US dollar

1,1869

JPY

Japanese yen

124,72

DKK

Danish krone

7,4396

GBP

Pound sterling

0,91423

SEK

Swedish krona

10,4118

CHF

Swiss franc

1,0753

ISK

Iceland króna

160,60

NOK

Norwegian krone

10,6608

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

26,726

HUF

Hungarian forint

358,54

PLN

Polish zloty

4,4466

RON

Romanian leu

4,8590

TRY

Turkish lira

8,8980

AUD

Australian dollar

1,6174

CAD

Canadian dollar

1,5628

HKD

Hong Kong dollar

9,1985

NZD

New Zealand dollar

1,7586

SGD

Singapore dollar

1,6110

KRW

South Korean won

1 390,72

ZAR

South African rand

19,3726

CNY

Chinese yuan renminbi

8,0229

HRK

Croatian kuna

7,5415

IDR

Indonesian rupiah

17 607,66

MYR

Malaysian ringgit

4,9025

PHP

Philippine peso

57,398

RUB

Russian rouble

88,8038

THB

Thai baht

36,913

BRL

Brazilian real

6,2211

MXN

Mexican peso

24,9614

INR

Indian rupee

87,2665


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


17.9.2020   

EN

Official Journal of the European Union

C 308/2


Notice pursuant to Article 6(6)(f) of Protocol II concerning the definition of the concept of ‘originating products’ and methods of administrative cooperation under the Interim Partnership Agreement between the European Community, of the one part and the Pacific States, of the other part

(2020/C 308/02)

By the present notice interested parties are informed that the Solomon Islands have made, on 18 May 2020, a notification to the European Commission in accordance with Article 6(6)(b) of Protocol II concerning the definition of the concept of ‘originating products’ and methods of administrative cooperation, as regards processed fishery products, under the Interim Partnership Agreement between the European Community, of the one part, and the Pacific States, of the other part (OJ L 272, 16.10.2009, p. 1).


Court of Auditors

17.9.2020   

EN

Official Journal of the European Union

C 308/3


Special Report 18/2020

The EU’s Emissions Trading System: free allocation of allowances needed better targeting

(2020/C 308/03)

The European Court of Auditors hereby informs you that Special Report 18/2020 ‘The EU’s Emissions Trading System: free allocation of allowances needed better targeting’ has just been published.

The report can be accessed for consultation or downloading on the European Court of Auditors’ website: http://eca.europa.eu


NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

17.9.2020   

EN

Official Journal of the European Union

C 308/4


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 2019

(2020/C 308/04)

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 2019, at their meeting on 20 March 2020.


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 2019:

Biocidal Product Name

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

Country

Date of decision

Boumatic Iodine product family

32019R1794

Iceland

30.1.2020

Boumatic Iodine product family

32019R1794

Liechtenstein

29.1.2020

Boumatic Iodine product family

32019R1794

Norway

20.1.2020

BPF_Iodine_VET

32019R1844

Iceland

30.1.2020

BPF_Iodine_VET

32019R1844

Liechtenstein

29.1.2020

CVAS Disinfectant product based on Propan-2-ol

32019R2029

Iceland

30.1.2020

CVAS Disinfectant product based on Propan-2-ol

32019R2029

Liechtenstein

29.1.2020

CVAS Disinfectant product based on Propan-2-ol

32019R2029

Norway

20.1.2020

Contec IPA Product Family

32019R2076

Iceland

30.1.2020

Contec IPA Product Family

32019R2076

Liechtenstein

29.1.2020

Contec IPA Product Family

32019R2076

Norway

20.1.2020

Pal IPA Product Family

32019R2030

Iceland

30.1.2020

Pal IPA Product Family

32019R2030

Liechtenstein

29.1.2020

Pal IPA Product Family

32019R2030

Norway

20.1.2020


17.9.2020   

EN

Official Journal of the European Union

C 308/6


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 2019

(2020/C 308/05)

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 2019, at their meeting on 20 March 2020.


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 2019:

Substance name

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

Country

Date of decision

Ammonium dichromate

C(2019) 5018

Iceland

14.8.2019

Ammonium dichromate

C(2019) 5018

Liechtenstein

16.8.2019

Ammonium dichromate

C(2019) 5018

Norway

15.8.2019

Arsenic acid

C(2019) 4134

Iceland

2.7.2019

Arsenic acid

C(2019) 4134

Liechtenstein

28.6.2019

Arsenic acid

C(2019) 4134

Norway

24.6.2019

Bis(2-methoxyethyl) ether (diglyme)

C(2019) 4123

Iceland

2.7.2019

Bis(2-methoxyethyl) ether (diglyme)

C(2019) 4123

Liechtenstein

28.6.2019

Bis(2-methoxyethyl) ether (diglyme)

C(2019) 4123

Norway

24.6.2019

Bis(2-methoxyethyl) ether (diglyme)

C(2019) 5096

Iceland

14.8.2019

Bis(2-methoxyethyl) ether (diglyme)

C(2019) 5096

Liechtenstein

16.8.2019

Bis(2-methoxyethyl) ether (diglyme)

C(2019) 5096

Norway

15.8.2019

Chromium trioxide

C(2019) 5022

Iceland

14.8.2019

Chromium trioxide

C(2019) 5022

Liechtenstein

16.8.2019

Chromium trioxide

C(2019) 5022

Norway

15.8.2019

Chromium trioxide

C(2019) 7441

Iceland

20.11.2019

Chromium trioxide

C(2019) 7441

Liechtenstein

7.11.2019

Chromium trioxide

C(2019) 7441

Norway

20.11.2019

Chromium trioxide

C(2019) 7448

Iceland

20.11.2019

Chromium trioxide

C(2019) 7448

Liechtenstein

7.11.2019

Chromium trioxide

C(2019) 7448

Norway

20.11.2019

Sodium chromate

C(2019) 7447

Iceland

20.11.2019

Sodium chromate

C(2019) 7447

Liechtenstein

7.11.2019

Sodium chromate

C(2019) 7447

Norway

20.11.2019

Sodium dichromate

C(2019) 4125

Iceland

2.7.2019

Sodium dichromate

C(2019) 4125

Liechtenstein

28.6.2019

Sodium dichromate

C(2019) 4125

Norway

24.6.2019

Sodium dichromate

C(2019) 3786

Iceland

11.9.2019

Sodium dichromate

C(2019) 3786

Liechtenstein

18.6.2019

Sodium dichromate

C(2019) 3786

Norway

24.6.2019

Sodium dichromate

C(2019) 7439

Iceland

20.11.2019

Sodium dichromate

C(2019) 7439

Liechtenstein

7.11.2019

Sodium dichromate

C(2019) 7439

Norway

20.11.2019

Pentazinc chromate octahydroxide

C(2019) 5023

Iceland

14.8.2019

Pentazinc chromate octahydroxide

C(2019) 5023

Liechtenstein

16.8.2019

Pentazinc chromate octahydroxide

C(2019) 5023

Norway

15.08.2019

Potassium dichromate

C(2019) 7683

Iceland

20.11.2019

Potassium dichromate

C(2019) 7683

Liechtenstein

13.11.2019

Potassium dichromate

C(2019) 7683

Norway

20.11.2019


17.9.2020   

EN

Official Journal of the European Union

C 308/9


Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the second half of 2019

(2020/C 308/06)

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 2019, at their meeting on 20 March 2020.

Annex I

List of new marketing authorisations

Annex II

List of renewed marketing authorisations

Annex III

List of extended marketing authorisations

Annex IV

List of withdrawn marketing authorisations

Annex V

List of suspended marketing authorisations


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 2019:

EU-Number

Product

Country

Date of authorisation

EU/2/19/240

Afoxolaner Merial

Iceland

30.8.2019

EU/1/19/1398

Arsenic Trioxide Accord

Iceland

2.12.2019

EU/1/19/1398

Arsenic Trioxide Accord

Liechtenstein

31.12.2019

EU/1/19/1398

Arsenic Trioxide Accord

Norway

26.11.2019

EU/2/18/228

Arti-Cell Forte

Iceland

16.7.2019

EU/1/19/1382

Azacitidin Celgene

Iceland

29.8.2019

EU/1/19/1382

Azacitidin Celgene

Liechtenstein

31.8.2019

EU/1/19/1382

Azacitidin Celgene

Norway

8.8.2019

EU/1/19/1406

BAQSIMI

Iceland

30.12.2019

EU/1/19/1406

BAQSIMI

Liechtenstein

31.12.2019

EU/1/19/1397

Bortezomib Fresenius Kabi

Iceland

29.11.2019

EU/1/19/1397

Bortezomib Fresenius Kabi

Liechtenstein

31.12.2019

EU/1/19/1397

Bortezomib Fresenius Kabi

Norway

10.12.2019

EU/1/19/1365

Cufence

Iceland

9.10.2019

EU/1/19/1365

Cufence

Liechtenstein

31.8.2019

EU/1/19/1365

Cufence

Norway

12.8.2019

EU/1/19/1386

Deferasirox Mylan

Iceland

11.10.2019

EU/1/19/1386

Deferasirox Mylan

Liechtenstein

31.10.2019

EU/1/19/1386

Deferasirox Mylan

Norway

8.10.2019

EU/1/19/1370

Dovato

Iceland

19.7.2019

EU/1/19/1370

Dovato

Liechtenstein

31.8.2019

EU/1/19/1370

Dovato

Norway

04.07.2019

EU/1/19/1389

Epidyolex

Iceland

18.10.2019

EU/1/19/1389

Epidyolex

Liechtenstein

31.10.2019

EU/1/19/1389

Epidyolex

Norway

16.10.2019

EU/1/19/1392

Ervebo

Iceland

4.12.2019

EU/1/19/1392

Ervebo

Liechtenstein

31.12.2019

EU/1/19/1392

Ervebo

Norway

19.11.2019

EU/1/19/1374

Esperoct

Liechtenstein

31.8.2019

EU/1/19/1411

Evenity

Iceland

12.12.2019

EU/1/19/1411

Evenity

Liechtenstein

31.12.2019

EU/2/19/242

EVICTO

Iceland

27.8.2019

EU/2/19/242

EVICTO

Liechtenstein

31.8.2019

EU/2/19/242

EVICTO

Norway

13.08.2019

EU/1/19/1384

Giapreza

Iceland

29.8.2019

EU/1/19/1384

Giapreza

Liechtenstein

31.8.2019

EU/1/19/1384

Giapreza

Norway

25.09.2019

EU/1/19/1375

Grasustek

Iceland

24.7.2019

EU/1/19/1375

Grasustek

Norway

31.10.2019

EU/2/19/245

Gumbohatch

Iceland

29.11.2019

EU/2/19/245

Gumbohatch

Liechtenstein

31.12.2019

EU/2/18/226

HorStem

Iceland

16.7.2019

EU/1/17/1216

Imraldi

Norway

16.09.2019

EU/1/19/1390

Inbrija

Iceland

11.10.2019

EU/1/19/1390

Inbrija

Liechtenstein

31.10.2019

EU/1/19/1390

Inbrija

Norway

16.10.2019

EU/1/19/1396

Ivozall

Iceland

28.11.2019

EU/1/19/1396

Ivozall

Norway

26.11.2019

EU/1/19/1383

Lacosamid UCB

Iceland

3.9.2019

EU/1/19/1383

Lacosamid UCB

Liechtenstein

31.8.2019

EU/1/19/1383

Lacosamid UCB

Norway

18.10.2019

EU/1/19/1376

LIBTAYO

Iceland

19.7.2019

EU/1/19/1376

LIBTAYO

Liechtenstein

31.8.2019

EU/1/19/1376

LIBTAYO

Norway

05.8.2019

EU/1/19/1381

LysaKare

Iceland

26.8.2019

EU/1/19/1381

LysaKare

Liechtenstein

31.8.2019

EU/1/19/1381

LysaKare

Norway

12.8.2019

EU/1/18/1301

Mepsevii

Liechtenstein

31.8.2019

EU/2/19/247

Mirataz

Iceland

30.12.2019

EU/2/19/247

Mirataz

Liechtenstein

31.12.2019

EU/2/19/241

NASYM

Iceland

27.8.2019

EU/2/19/241

NASYM

Liechtenstein

31.8.2019

EU/2/19/241

NASYM

Norway

16.8.2019

EU/2/19/246

Neptra

Iceland

30.12.2019

EU/2/19/246

Neptra

Liechtenstein

31.12.2019

EU/2/19/244

Nobivac Myxo-RHD Plus

Iceland

4.12.2019

EU/2/19/244

Nobivac Myxo-RHD Plus

Liechtenstein

31.12.2019

EU/1/19/1364

Nuceiva

Iceland

18.10.2019

EU/1/19/1364

Nuceiva

Norway

18.10.2019

EU/1/18/1320

Onpattro

Liechtenstein

31.12.2019

EU/1/19/1388

Polivy

Liechtenstein

31.12.2019

EU/1/19/1379

Posaconazole Accord

Iceland

28.8.2019

EU/1/19/1379

Posaconazole Accord

Liechtenstein

31.8.2019

EU/1/19/1379

Posaconazole Accord

Norway

26.8.2019

EU/1/19/1380

Posaconazole AHCL

Iceland

27.8.2019

EU/1/19/1380

Posaconazole AHCL

Liechtenstein

31.8.2019

EU/1/19/1380

Posaconazole AHCL

Norway

12.8.2019

EU/1/19/1401

Qtrilmet

Iceland

18.11.2019

EU/1/19/1401

Qtrilmet

Liechtenstein

31.12.2019

EU/1/19/1401

Qtrilmet

Norway

6.12.2019

EU/1/19/1393

Quofenix

Iceland

30.12.2019

EU/1/19/1393

Quofenix

Liechtenstein

31.12.2019

EU/1/19/1400

Rhokiinsa

Iceland

5.12.2019

EU/1/19/1400

Rhokiinsa

Norway

17.12.2019

EU/1/19/1404

Rinvoq

Iceland

30.12.2019

EU/1/19/1404

Rinvoq

Liechtenstein

31.12.2019

EU/1/19/1387

Senstend

Iceland

4.12.2019

EU/1/19/1387

Senstend

Norway

4.12.2019

EU/2/19/243

Simparica Trio

Iceland

10.10.2019

EU/2/19/243

Simparica Trio

Liechtenstein

31.10.2019

EU/2/19/243

Simparica Trio

Norway

11.11.2019

EU/1/19/1369

Sixmo

Iceland

17.7.2019

EU/1/19/1369

Sixmo

Norway

15.7.2019

EU/1/19/1410

Spravato

Liechtenstein

31.12.2019

EU/1/19/1372

Striascan

Iceland

2.7.2019

EU/1/19/1372

Striascan

Liechtenstein

31.8.2019

EU/1/19/1372

Striascan

Norway

11.7.2019

EU/1/19/1377

Talzenna

Iceland

16.7.2019

EU/1/19/1377

Talzenna

Norway

15.7.2019

EU/1/19/1359

Trogarzo

Iceland

5.11.2019

EU/1/19/1359

Trogarzo

Liechtenstein

31.10.2019

EU/1/19/1359

Trogarzo

Norway

18.10.2019

EU/1/19/1371

Ultomiris

Iceland

22.7.2019

EU/1/19/1371

Ultomiris

Liechtenstein

31.8.2019

EU/1/19/1371

Ultomiris

Norway

17.7.2019

EU/1/19/1385

VITRAKVI

Iceland

5.11.2019

EU/1/19/1385

VITRAKVI

Liechtenstein

31.10.2019

EU/1/19/1385

VITRAKVI

Norway

18.10.2019

EU/1/18/1312

Xerava

Liechtenstein

31.12.2019

EU/1/19/1399

Xospata

Iceland

6.11.2019

EU/1/19/1399

Xospata

Norway

30.10.2019

EU/1/19/1366

Xromi

Iceland

19.7.2019

EU/1/19/1366

Xromi

Liechtenstein

31.8.2019

EU/1/19/1366

Xromi

Norway

17.7.2019


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 2019:

EU-Number

Product

Country

Date of authorisation

EU/1/14/944

Abasaglar

Iceland

28.8.2019

EU/1/14/944

Abasaglar

Liechtenstein

31.8.2019

EU/1/14/944

Abasaglar

Norway

16.8.2019

EU/1/12/794

ADCETRIS

Iceland

18.10.2019

EU/1/12/794

ADCETRIS

Norway

29.10.2019

EU/1/09/578

Adjupanrix

Iceland

29.8.2019

EU/1/09/578

Adjupanrix

Norway

12.8.2019

EU/1/17/1214

Bavencio

Liechtenstein

31.10.2019

EU/2/14/176

Bovela

Iceland

15.11.2019

EU/2/14/176

Bovela

Liechtenstein

31.12.2019

EU/2/14/176

Bovela

Norway

27.11.2019

EU/1/14/963

Brimica Genuair

Iceland

29.8.2019

EU/1/14/963

Brimica Genuair

Liechtenstein

31.8.2019

EU/1/14/963

Brimica Genuair

Norway

20.09.2019

EU/1/14/951

Busulfan Fresenius Kabi

Norway

15.07.2019

EU/1/14/974

Cerdelga

Iceland

30.12.2019

EU/1/14/974

Cerdelga

Liechtenstein

31.12.2019

EU/1/14/975

Clopidogrel ratiopharm

Iceland

15.11.2019

EU/1/14/975

Clopidogrel ratiopharm

Liechtenstein

31.12.2019

EU/1/14/975

Clopidogrel ratiopharm

Norway

9.12.2019

EU/1/13/890

Cometriq

Norway

3.07.2019

EU/1/14/980

Cosentyx

Iceland

10.9.2019

EU/1/14/980

Cosentyx

Liechtenstein

31.10.2019

EU/1/14/980

Cosentyx

Norway

18.09.2019

EU/1/17/1262

Crysvita

Iceland

27.12.2019

EU/1/17/1262

Crysvita

Liechtenstein

31.12.2019

EU/1/14/957

Cyramza

Iceland

10.10.2019

EU/1/14/957

Cyramza

Norway

3.10.2019

EU/1/14/964

Duaklir Genuair

Iceland

29.8.2019

EU/1/14/964

Duaklir Genuair

Liechtenstein

31.8.2019

EU/1/14/964

Duaklir Genuair

Norway

20.09.2019

EU/1/14/960

DUAVIVE

Iceland

15.11.2019

EU/1/14/960

DUAVIVE

Liechtenstein

31.12.2019

EU/1/14/960

DUAVIVE

Norway

9.12.2019

EU/1/14/972

Duloxetin Lilly

Iceland

28.8.2019

EU/1/14/972

Duloxetin Lilly

Liechtenstein

31.8.2019

EU/1/14/972

Duloxetin Lilly

Norway

30.8.2019

EU/1/14/983

Exviera

Iceland

10.10.2019

EU/1/14/983

Exviera

Norway

18.10.2019

EU/1/09/601

Firdapse

Iceland

30.8.2019

EU/1/09/601

Firdapse

Liechtenstein

31.8.2019

EU/1/09/601

Firdapse

Norway

18.9.2019

EU/1/14/958

Harvoni

Iceland

29.8.2019

EU/1/14/958

Harvoni

Liechtenstein

31.8.2019

EU/1/14/958

Harvoni

Norway

16.8.2019

EU/1/14/945

IMBRUVICA

Iceland

16.7.2019

EU/1/14/945

IMBRUVICA

Liechtenstein

31.8.2019

EU/1/14/945

IMBRUVICA

Norway

2.7.2019

EU/1/09/531

Instanyl

Iceland

23.7.2019

EU/1/09/531

Instanyl

Liechtenstein

31.8.2019

EU/1/09/531

Instanyl

Norway

16.7.2019

EU/1/15/994

Kengrexal

Iceland

27.12.2019

EU/1/15/994

Kengrexal

Liechtenstein

31.12.2019

EU/1/14/965

Ketoconazole HRA

Iceland

5.9.2019

EU/1/14/965

Ketoconazole HRA

Liechtenstein

31.8.2019

EU/1/14/965

Ketoconazole HRA

Norway

12.8.2019

EU/1/14/955

Lymphoseek

Iceland

18.10.2019

EU/1/14/955

Lymphoseek

Norway

25.9.2019

EU/1/14/959

Lynparza

Iceland

10.10.2019

EU/1/14/959

Lynparza

Norway

18.10.2019

EU/1/14/962

Moventig

Iceland

9.10.2019

EU/1/14/962

Moventig

Norway

31.10.2019

EU/1/09/591

Multaq

Iceland

9.10.2019

EU/1/09/591

Multaq

Norway

21.10.2019

EU/2/14/177

Nexgard Spectra

Iceland

15.11.2019

EU/2/14/177

Nexgard Spectra

Liechtenstein

31.12.2019

EU/2/14/177

Nexgard Spectra

Norway

27.11.2019

EU/1/16/1094

Ninlaro

Iceland

18.10.2019

EU/1/14/979

Ofev

Iceland

18.10.2019

EU/1/14/979

Ofev

Norway

21.10.2019

EU/2/14/170

Osurnia

Iceland

22.7.2019

EU/2/14/170

Osurnia

Liechtenstein

31.8.2019

EU/2/14/170

Osurnia

Norway

16.7.2019

EU/1/14/981

Otezla

Iceland

30.8.2019

EU/1/14/981

Otezla

Liechtenstein

31.8.2019

EU/1/14/981

Otezla

Norway

28.9.2019

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Norway

8.7.2019

EU/2/14/175

Porcilis PCV M Hyo

Iceland

9.10.2019

EU/2/14/175

Porcilis PCV M Hyo

Norway

14.10.2019

EU/1/14/977

Rasagiline ratiopharm

Iceland

21.10.2019

EU/1/14/967

Rezolsta

Iceland

28.8.2019

EU/1/14/967

Rezolsta

Liechtenstein

31.8.2019

EU/1/14/967

Rezolsta

Norway

16.8.2019

EU/1/14/970

RIXUBIS

Iceland

5.12.2019

EU/1/15/992

Saxenda

Iceland

27.12.2019

EU/1/15/992

Saxenda

Liechtenstein

31.12.2019

EU/1/14/969

SCENESSE

Iceland

5.12.2019

EU/1/14/969

SCENESSE

Liechtenstein

31.12.2019

EU/1/14/969

SCENESSE

Norway

6.12.2019

EU/1/14/978

Senshio

Iceland

6.11.2019

EU/1/14/978

Senshio

Liechtenstein

31.10.2019

EU/1/14/978

Senshio

Norway

21.11.2019

EU/1/14/952

Sevelamer carbonate Winthrop

Iceland

15.11.2019

EU/1/14/952

Sevelamer carbonate Winthrop

Liechtenstein

31.12.2019

EU/1/14/952

Sevelamer carbonate Winthrop

Norway

27.11.2019

EU/2/14/179

Suvaxyn CSF Marker

Iceland

15.11.2019

EU/2/14/179

Suvaxyn CSF Marker

Liechtenstein

31.12.2019

EU/2/14/179

Suvaxyn CSF Marker

Norway

27.11.2019

EU/1/14/961

Tadalafil Mylan

Iceland

28.8.2019

EU/1/14/961

Tadalafil Mylan

Liechtenstein

31.8.2019

EU/1/14/961

Tadalafil Mylan

Norway

12.8.2019

EU/1/13/902

Translarna

Iceland

28.8.2019

EU/1/13/902

Translarna

Liechtenstein

31.8.2019

EU/1/13/902

Translarna

Norway

26.8.2019

EU/1/14/971

TREVICTA

Iceland

6.12.2019

EU/1/14/971

TREVICTA

Norway

4.12.2019

EU/1/14/940

Triumeq

Iceland

21.10.2019

EU/1/14/940

Triumeq

Norway

16.8.2019

EU/1/14/956

Trulicity

Iceland

29.8.2019

EU/1/14/956

Trulicity

Liechtenstein

31.8.2019

EU/1/14/956

Trulicity

Norway

25.9.2019

EU/1/07/440

Tyverb

Iceland

9.10.2019

EU/1/07/440

Tyverb

Norway

21.10.2019

EU/1/14/954

Vargatef

Iceland

29.8.2019

EU/1/14/954

Vargatef

Liechtenstein

31.8.2019

EU/1/14/954

Vargatef

Norway

2.9.2019

EU/1/07/423

Vectibix

Iceland

9.10.2019

EU/1/07/423

Vectibix

Norway

21.10.2019

EU/1/14/982

Viekirax

Iceland

18.10.2019

EU/1/14/982

Viekirax

Norway

18.10.2019

EU/1/14/941

Vizamyl

Iceland

28.8.2019

EU/1/14/941

Vizamyl

Liechtenstein

31.8.2019

EU/1/14/941

Vizamyl

Norway

12.8.2019

EU/1/14/984

Xadago

Iceland

9.10.2019

EU/1/14/947

Xultophy

Iceland

21.10.2019

EU/1/14/947

Xultophy

Norway

7.8.2019

EU/1/14/986

Xydalba

Iceland

12.12.2019

EU/1/14/986

Xydalba

Liechtenstein

31.12.2019


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 2019:

EU-Number

Product

Country

Date of authorisation

EU/1/13/853/006-014

Remsima

Iceland

5.12.2019

EU/1/15/1043/003-006

Nucala

Iceland

28.8.2019

EU/1/15/1043/003-006

Nucala

Norway

31.7.2019

 

 

 

 

EU/1/17/1216/009

Imraldi

Iceland

30.8.2019

EU/1/17/1220/002

Tecentriq

Iceland

30.8.2019

EU/1/17/1220/002

Tecentriq

Norway

26.8.2019

 

 

 

 

EU/1/12/782/006

Kalydeco

Norway

17.12.2019


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 2019:

EU-Number

Product

Country

Date of withdrawal

EU/1/16/1122

Aerivio Spiromax

Iceland

21.10.2019

EU/1/16/1122

Aerivio Spiromax

Norway

29.10.2019

EU/1/07/390

Altargo

Iceland

28.8.2019

EU/2/99/017

Bovalto Ibraxion

Iceland

16.7.2019

EU/1/14/939

Daklinza

Iceland

13.12.2019

EU/1/15/1077

Iblias

Iceland

10.9.2019

EU/1/15/1077

Iblias

Liechtenstein

31.10.2019

EU/1/15/1077

Iblias

Norway

3.9.2019

EU/2/17/208

Ingelvac PCV FLEX

Norway

23.08.2019

EU/1/19/1357

Kromeya

Liechtenstein

31.12.2019

EU/1/19/1357

Kromeya

Norway

17.12.2019

EU/1/16/1143

Lartruvo

Iceland

26.8.2019

EU/1/16/1143

Lartruvo

Liechtenstein

31.8.2019

EU/1/16/1143

Lartruvo

Norway

5.8.2019

EU/1/13/847

MACI

Iceland

6.11.2019

EU/1/16/1100

Palonosetron Hospira

Iceland

2.7.2019

EU/1/16/1100

Palonosetron Hospira

Norway

23.8.2019

EU/1/13/849

Somatropin Biopartners

Norway

26.8.2019

EU/1/16/1131

Thorinane

Iceland

6.11.2019

EU/1/09/552

Topotecan Teva

Norway

23.08.2019

EU/1/16/1121

Zalmoxis

Iceland

18.10.2019

EU/1/16/1121

Zalmoxis

Norway

30.10.2019


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 2019:

EU-Number

Product

Country

Date of suspension

 

 

 

 


V Announcements

COURT PROCEEDINGS

EFTA Court

17.9.2020   

EN

Official Journal of the European Union

C 308/21


Request for an Advisory Opinion from the EFTA Court by Borgarting Lagmannsrett dated 11 May 2020 in the case of Tor-Arne Martinez Haugland v The Norwegian Government

(Case E-4/20)

(2020/C 308/07)

A request has been made to the EFTA Court dated 11 May 2020 from Borgarting Lagmannsrett (Borgarting Court of Appeal), which was received at the Court Registry on 11 May 2020, for an Advisory Opinion in the case of Tor-Arne Martinez Haugland v The Norwegian Government on the following questions:

1.

In connection with the assessment of ‘same profession’, see Articles 1 and 4 of the Directive, answers are requested to the following questions:

a.

What is the legal assessment and what are the legally relevant factors in the determination of whether a profession in the State where the qualification was obtained and that in the host State constitute the ‘same profession’?

b.

In the determination of ‘same profession’, must the host State take account of professional activities which the applicant in question may pursue in the State where the qualification was obtained, only under supervision and on the condition that the applicant has commenced a course of further education and training or undertaken to commence such a course of education and training within two years? If so, is it of any consequence that the applicant has opted not to commence or undertake to commence such a course of further education and training?

c.

What importance does differences in degree of independence in pursuing a profession and responsibility for patients have in the determination of whether it is the ‘same profession’?

2.

Does the possibility of requiring compensation measures, see Article 14 of Directive 2005/36/EC, have any bearing on the interpretation of what constitutes ‘same profession’? If so, what importance does this have?

3.

What is the specific legal assessment under Article 2(1)(e) of Directive 2005/36/EC, which provides that regulated education and training must be ‘specifically geared to the pursuit of a given profession’?

4.

In connection with Articles 28 and 31 of the EEA Agreement, answers are requested to the following:

a.

Where an applicant does not fulfil the requirements for having qualifications recognised under Article 13 of the Professional Qualifications Directive, read in conjunction with Article 14, may the applicant rely on Articles 28 and 31 of the EEA Agreement as a basis for pursuing the regulated profession in the host State?

b.

If question a is answered in the affirmative, what is then the legally relevant assessment for the examination under Articles 28 and 31?


OTHER ACTS

European Commission

17.9.2020   

EN

Official Journal of the European Union

C 308/22


Publication of an application for registration of a name pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

(2020/C 308/08)

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

SINGLE DOCUMENT

‘Huile de noix du Périgord’

EU No: PDO-FR-2445 – 20.12.2018

PDO (X) PGI ( )

1.   Name(s)

‘Huile de noix du Périgord’

2.   Member State or Third Country

France

3.   Description of the agricultural product or foodstuff

3.1.   Type of product

Class 1.5: Oils and fats (butter, margarine, oil, etc.)

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

‘Huile de noix du Périgord’ is a virgin, first-pressed walnut oil, extracted through solely mechanical processes.

The oil is produced exclusively from the Franquette, Marbot, Corne et Grandjean walnut varieties.

Cold-pressed walnut oil has a colour ranging from straw-yellow with pale green highlights to golden yellow. It has a clear appearance and a fluid texture. The oil has an intense and sustained aroma of nuts and freshly baked bread crumb with aromatic green notes and the scent of fresh walnuts. Its delicate aromas last well on the palate.

Hot-pressed walnut oil has a colour ranging from golden yellow to golden brown. It has a clear appearance and tends to coat the mouth. The oil has a fruity, intense scent of walnuts, freshly baked bread crust, with notes of gentle roasting/toasting, finished off with the smell of toast and biscuits, which give it roundness and ensure it lasts well on the palate.

Maximum acid content is 4 mg KOH/g of oil.

The peroxide value is 15 milliequivalents of active oxygen per 1 kg of walnut oil or less.

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

‘Huile de noix du Périgord’ is produced from walnut kernels grown in the geographical area, that are

dried naturally on wooden slats or in hot dry air flows. In the latter case, the air flow must be capable of passing through the whole mass of nuts to be dried and must not exceed 30 °C,

cracked either by hand or by machine, and

shelled by hand or machine.

At least 50 % of the walnut kernels used to produce the oil must be of the Franquette variety.

Mouldy or rotten kernels are not used to produce the oil.

Kernels intended for the manufacture of ‘Huile de noix du Périgord’ may be mixed in shape and colour (top quality walnuts, broken walnuts, light or dark brown in colour, halved, broken pieces or crumbs).

In all cases, the flesh of the kernel must be white, and walnut crumbs may not exceed 20 % of the total weight of the raw material used.

Dried walnuts and walnut kernels used in the manufacture of ‘Huile de noix du Périgord’ are stored from 1 March of the year following that of the harvest at a temperature between 2 °C and 8 °C and at a relative humidity of between 60 and 75 %.

Beyond 31 October of the year following that of the harvest, the walnuts and kernels are no longer used to produce the ‘Huile de noix du Périgord’ PDO. It is forbidden to use a mix of kernels from different harvests.

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

All the stages, from growing the walnuts to producing the ‘Huile de noix du Périgord’, must take place in the geographical area.

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

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

In addition to the compulsory information required by the rules on the labelling and presentation of foodstuffs, the labelling of oils bearing the designation of origin ‘Huile de noix du Périgord’ must include the following information on the main label:

the name of the designation of origin ‘Huile de noix du Périgord’ written in a font at least as large as the largest font used on the label,

the additional words ‘cold-pressed’ for the oils where this applies,

where the words ‘protected designation of origin’ or ‘PDO’ are used, they must appear immediately below the name of the designation.

4.   Concise definition of the geographical area

The geographical area is made up of 645 municipalities in the Departments of Aveyron, Charente, Corrèze, Dordogne, Lot, and Lot-et-Garonne.

5.   Link with the geographical area

The link with the geographical area is based on certain specific product characteristics (the walnut variety, the aromatic balance conferred by the extraction methods), which it owes to the natural and human factors that are characteristic of the geographical area and thanks to which it enjoys an excellent reputation.

The product ‘Huile de noix du Périgord’ is produced in a traditional area of walnut and walnut-kernel production.

As regards the natural factors, the geographical area has a climate that is well suited to growing walnut trees. It is located mainly in the Piedmont area of the Massif Central, a region with hot summers and heavy rainfall.

It can be described as an ascending staircase consisting of three steps facing south-west to north-east:

The first step consisting of Cretaceous secondary marine limestone,

The second step consisting of Jurassic marine limestone,

The last step falling within the Bas-Limousin plateau, the first foothill of the Massif Central.

All three areas feature well-structured and naturally drained soils.

The Dordogne and its main tributaries form a dense river network fanning out from the Massif Central to the Atlantic. The area is also intersected to the south by the Lot valley.

As regards human factors, the craft of oil pressing was widespread as early as in the 12th century in the Périgord, as attested by the presence of a large number of oil presses at that time.

After harvesting, the walnuts are shelled, and the kernels are sorted according to shape and colour, which determines how they will be used and their quality. Kernels used for the production of walnut oil are generally broken or fragmented during shelling, and are healthy and have white flesh.

The traditional mill consists of a stone wheel (granite, flint or sandstone) for grinding the kernels, a cast-iron skillet and a wood fire for heating the paste, and a press to press the paste and extract the oil. This type of mill is still used in the geographical area.

The modernisation of production systems and the use of new materials made it easier for manufacturers to improve yields. Electrical energy has replaced haulage by livestock and hydraulic energy is now used to operate the grinding wheel. Over time, copper and stainless steel skillets appeared with gas cookers, which are easier to control. Almost half of the oil mills use manual or semi-industrial meat mincers. The aim is to obtain a homogeneous paste. Heating the paste is optional.

The paste is then pressed mechanically by means of a hydraulic mechanism, a water wheel, an electric motor, or manually using levers or wooden plates. After extraction, the walnut oil is decanted at room temperature in order obtain clear walnut oil. It can be filtered through paper filters.

Alongside traditional oil mills – which constitute genuine engineering heritage that oil milling serves to maintain and preserve – more modern mills with continuous extraction have been introduced.

‘Huile de noix du Périgord’ owes its main characteristics to the use of quality walnut kernels from traditional local varieties and/or well adapted to the soil and weather conditions in the production area: the Marbot, Corne, Grandjean and Franquette varieties.

This oil also stands out on account of its good aromatic balance and noticeably fruity walnut aromas, however the oil has been extracted.

Delicate aromas, roundness and the ability to last on the palate are specific to the ‘Huile de noix du Périgord’.

The natural characteristics of the area, together with the know-how of walnut growers and producers constitute a coincidence of links that give the finished product a distinctiveness recognised by consumers, which, in turn, helps contribute to the reputation of ‘Huile de noix du Périgord’.

The production area is characterised by soil and weather conditions that are conducive to walnut trees achieving good growth and producing quality walnuts: the soils are well structured and have natural drainage, rainfall is adapted to the needs of the trees during the growth of the kernel, the Massif Central affords physical protection against the cold air sweeping in from the north, and the area warms quicker in spring due to the south-west exposure of the walnut groves.

The presence of many rivers and streams has enabled the construction of many mills and oil presses using hydraulic power.

Corne, Marbot and Grandjean are indigenous varieties that have not spread outside their native region, and have found a particularly suitable environment for production. The soil and climate conditions in the production area have been favourable to the growth of the Franquette variety. The local varieties selected are all hardy varieties with terminal fruiting, and this gives rise to non-intensive cultivation techniques. This has favoured practices at grove level, particularly in relation to density, intercropping or irrigation.

The use of these varieties in the processing of oil takes contributes to the production of the typical aromatic characteristic of ‘Huile de noix du Périgord’.

Thanks to the thorough knowledge of the environment (nature, soil structure and depth, topography and exposure), producers have planted their orchards in areas conducive to the production of quality walnut kernels. The use of this raw material is essential in order to produce a quality walnut oil and, at the time of processing, it allows the expression of delicate nutty aromas characteristic of ‘Huile de noix du Périgord’.

The development of local know-how about the stages of shelling and drying of the walnuts allows for the growth of quality fruit, and contributes to the development of an aromatic and fruity oil.

The production area of ‘Huile de noix du Périgord’ corresponds to the traditional production area of the ‘Noix du Périgord’ PDO, renowned for the production of fresh and dry walnuts and walnut kernels.

The careful selection of the raw material attests to the know-how of the processors/oil producers. Kernels are sorted and selected according to colour and shape. Poor-quality kernels are excluded from production. These steps guarantee the quality of the kernels and the production of an aromatic and fruity oil, which lasts well on the palate.

This expertise is also revealed in the thorough knowledge of extraction techniques, essential for preserving the oil’s aromatic potential and for the full expression of the aromas of nuts, freshly baked bread crumb and fresh walnuts for cold-pressed oil, and of fruity walnut and freshly baked bread crust for the hot-pressed oil.

Temperature control during heating (where it is used) is the decisive step in ensuring the oil’s aromatic balance. It is said that the oil producer's reputation stands for falls during the heating phase. When the temperature of the paste increases, the intensity of the fruity aromas gradually shift towards toasted/roasted notes. The oil producer regulates the temperature according to the desired aromatic balance and the desired toasted/roasted intensity. The oil producer also regularly stirs the paste to ensure that it remains homogeneous and to prevent it from burning. This know-how helps the oil producer prevent the temperature from exceeding 100 °C, which would result in the loss of the fruity walnut aromas and a preponderance of overly pronounced toasted/roasted aromas and unpleasant burnt smells.

Mastering extraction techniques also makes it possible to obtain varying colours of oil, ranging from straw-yellow to golden brown.

Decanting and storage away from light and heat contribute to the production of a clear nut oil and the conservation of its aromas.

Re-establishing the importance of walnut production is crucial to the production area, in particular on account of the reputation of ‘Noix du Périgord’ PDO. This re-establishment has taken the form of the sustained development of walnut groves in recent years, the maintenance of walnut oil production and even an increase in volumes marketed, thanks to the promotion of the product on markets, trade fairs, festivals and, more recently, the introduction of an annual regional competition for walnut oil produced in the Périgord. Also, in 2003, the union established the walnut tree and nut route in the Périgord. Finally, it is a product that is strongly linked to the Périgord's gastronomic heritage, to a particular know-how to which it owes its reputation. The ‘Huile de noix du Périgord’ receives awards regularly in the open competition for agriculture.

Reference to publication of the specification

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

https://extranet.inao.gouv.fr/fichier/CDC-HuileNPerigord.pdf


(1)  OJ L 343, 14.12.2012, p. 1.


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