ISSN 1977-091X |
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Official Journal of the European Union |
C 308 |
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English edition |
Information and Notices |
Volume 63 |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2020/C 308/01 |
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2020/C 308/02 |
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Court of Auditors |
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2020/C 308/03 |
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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
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Standing Committee of the EFTA States |
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2020/C 308/04 |
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2020/C 308/05 |
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2020/C 308/06 |
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V Announcements |
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COURT PROCEEDINGS |
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EFTA Court |
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2020/C 308/07 |
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OTHER ACTS |
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European Commission |
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2020/C 308/08 |
EN |
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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:
|
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:
|
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