ddrg/super_eurlex huggingface dataset:
COVID-19 outbreak

(Regulation (EU) 2021/267 of the European Parliament and of the Council of 16 February 2021 laying down specific and temporary measures in view of the persistence of the COVID-19 crisis concerning the renewal or extension of certain certificates, licences and authorisations, the postponement of certain periodic checks and periodic training in certain areas of transport legislation and the extension of certain periods referred to in Regulation (EU) 2020/698 (1))

(2021/C 76 I/03)

Denmark

Date of the Information to the Commission: 23.2.2021

Denmark has decided, in conformity with the relevant provisions of Regulation (EU) 2021/267 of the European Parliament and of the Council that it shall not apply the following provisions:

— Article 4(1) concerning the regular inspections of tachographs in road transport under Regulation (EU) No 165/2014 (2);

— Article 5(1) concerning the time limits for the periodic roadworthiness tests for motor vehicles and their trailers under Directive 2014/45/EU (3);

— Article 5(2) concerning the validity of roadworthiness certificates under Directive 2014/45/EU.

(1) OJ L 60, 22.2.2021, p. 1.

(2) Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport, repealing Council Regulation (EEC) No 3821/85 on recording equipment in road transport and amending Regulation (EC) No 561/2006 of the European Parliament and of the Council on the harmonisation of certain social legislation relating to road transport (OJ L 60, 28.2.2014, p. 1).

(3) Directive 2014/45/EU of the European Parliament and of the Council of 3 April 2014 on periodic roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC (OJ L 127, 29.4.2014, p. 51).
Information communicated by Member States regarding closure of fisheries

(2021/C 80 I/02)

In accordance with Article 35(3) of Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy (1), a decision has been taken to close the fishery as set down in the following table:

Date and time of closure 24.12.2020 Duration 24.12.2020 - 31.12.2020 Member State Belgium Stock or Group of stocks PLE/07A. Species Plaice (Pleuronectes platessa) Zone 7a Type(s) of fishing vessels --- Reference number 36/TQ123

(1) OJ L 343, 22.12.2009, p. 1.
Information communicated by Member States regarding closure of fisheries

(2021/C 83 I/01)

In accordance with Article 35(3) of Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy (1), a decision has been taken to close the fishery as set down in the following table:

Date and time of closure 24.12.2020 Duration 24.12.2020 - 31.12.2020 Member State Portugal Stock or Group of stocks ALB/AN05N Species Northern albacore (Thunnus alalunga) Zone Atlantic Ocean, north of 5° N Type(s) of fishing vessels --- Reference number 40/TQ123

(1) OJ L 343, 22.12.2009, p. 1.
Addendum to the Publication of the list of standard amendments to the product specifications for PDO and PGI wines

(2021/C 143/08)

This addendum supplements the publication of the list of standard amendments to the product specifications for PDO and PGI wines (1) per Member State in accordance with Article 61(6) of Commission Delegated Regulation (EU) 2019/33 (2).

The Commission will make public the applications and the single documents related to those standard amendments in accordance with the said Article, in the electronic register of PDO and PGI established in accordance with Article 104 of Regulation (EU) No 1308/2013 (3)(eAmbrosia – the EU geographical indications register).

Country Wine names File number Italy Terre Siciliane PGI-IT-A0810-AM03

(1) Publication of the list of standard amendments to the product specifications for PDO and PGI wines (2019/C 225/06), OJ C 225, 5.7.2019, p. 38.

(2) Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards applications for protection of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to product specifications, cancellation of protection, and labelling and presentation (OJ L 9, 11.1.2019, p. 2).

(3) Regulation (EU) No 1308/2013 of the European Parlament an dof the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).
Official Journal of the European Union

Commission notice pursuant to Article 16(4) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community

Changes to public service obligations in respect of scheduled air services

(Text with EEA relevance)

(2021/C 173/04)
Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2021 to 30 April 2021

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2021/C 204/02)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorisation Member State concerned Date of notification 21.4.2021 Varilrix and associated names Live attenuated varicella virus (OKA strain) See Annex See Annex 22.4.2021

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.
Official Journal of the European Union

COMMUNICATION FROM THE COMMISSION

on the body authorised to issue certificates of authenticity under Implementing Regulation (EU) No 2020/1988

(2021/C 187/04)

Council Regulation (EC) No 617/2009 of 13 July 2009 opening an autonomous tariff quota for imports of high-quality beef (1) was amended by Regulation (EU) No 464/2012 of the European Parliament and of the Council (2).

Commission Regulation (EC) No 620/2009 of 13 July 2009 providing for the administration of an import tariff quota for high-quality beef (3) was repealed and replaced by Commission Implementing Regulation (EU) No 481/2012 of 7 June 2012 providing for the administration of an import tariff quota for high-quality beef (4).

Commission Implementing Regulation (EU) No 481/2012 of 7 June 2012 providing for the administration of an import tariff quota for high-quality beef was repealed by Commission Delegated Regulation (EU) 2020/1987 and replaced by Commission Implementing Regulation (EU) No 2020/1988 (5).

Under Article 25 of Implementing Regulation (EU) No 2020/1988, the release into free circulation of goods imported under the quota bearing the orders numbers 09.2201, 09.2202 and 09.2203, is subject to the presentation of a certificate of authenticity.

The following issuing authorities are authorised to issue certificates of authenticity under Implementing Regulation (EU) No 2020/1988:

Department of Agriculture, Fisheries and Forestry (DAFF) of the Australian Government 18 Marcus Clarke Street Canberra City ACT 2601 AUSTRALIA

Contact point: Biosecurity Service Group Mr Greg READ, Executive Manager Tel. +61 262723594 Email: pr@aqis.gov.au

Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) Washington D.C., 20250 UNITED STATES OF AMERICA Internet: http://www.fsis.usda.gov

Canadian Food Inspection Agency (CFIA) 1400 Merivale Road Ottawa, Ontario K1A 0Y9 CANADA Email: bertrand.st-arnaud@inspection.gc.ca Internet: http://www.inspection.gc.ca

Ministry of Agriculture and Forestry Pastoral House 25 The Terrace PO Box 2526 Wellington 6140 NEW ZEALAND

Tel. +64 48940100

Fax +64 48940720

Email: nzfsa.info@maf.govt.nz

Internet: http://www.maf.govt.nz

Ministerio de Ganadería, Agricultura y Pesca Dirección General de Servicios Ganaderos División Industria Animal Ruta 8, km 17.500 Montevideo URUGUAY

Tel. +598 22204000

Fax +598 22204000 Ext. 150 801

Email: dgsg@mgap.gub.uy

iInternet: http://www.mgap.gub.uy/unidad-organizativa/direccion-general-de-servicios-ganaderos

Ministerio de Agricultura, Ganaderia y Pesca de la Republica Argentina Paseo Colon 982 (C1063ACW) Buenos Aires Republica Argentina

Tel. + 54 1143492000

Fax + 54 1143492000

Internet: https://www.argentina.gob.ar/agricultura-ganaderia-y-pesca

(1) OJ L 182, 15.7.2009, p. 1.

(2) OJ L 149, 8.6.2012, p. 1.

(3) OJ L 182, 15.7.2009, p. 25.

(4) OJ L 148, 8.6.2012, p. 9.

(5) OJ L 422, 14.12.2020, p. 4.
Notice on the application of the trade defence legislation and measures of the European Union in Northern Ireland from 1 January 2021

(2021/C 248/03)

As recalled in the notice of 18 January 2021 (1), the trade defence legislation and measures of the European Union ceased to apply in the United Kingdom as of 1 January 2021. However, Article 5(4) of the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) (2), which applies as from that date (3), provides that the trade defence legislation continues to be applicable to and in the United Kingdom in respect of Northern Ireland. The IE/NI Protocol is subject to periodic consent of the Northern Ireland Legislative Assembly, the initial period of application extending to 4 years after the end of the transition period (4).

The IE/NI Protocol, as amended by Decision No 3/2020 of the Joint Committee of 17 December 2020 (5), provides for the application of certain provisions of EU law concerning trade defence to and in the United Kingdom in respect of Northern Ireland, subject to the Explanatory Notes included in Annex 2 to the IE/NI Protocol by that Decision. The situation can be summarised as follows.

The United Kingdom in respect of Northern Ireland is not part of the Union or a Member State within the meaning of the Union trade defence legislation. The market of and the economic operators located in Northern Ireland are considered to be the market of and economic operators located in a country not member of the European Union. However, the Union’s trade defence measures are applicable on goods brought into Northern Ireland from outside the Union (including from other parts of the UK), in accordance with the provisions of Article 5 of the IE/NI Protocol, as further specified by Decision No 4/2020 of the Joint Committee of 17 December 2020 (6).

Lastly, importers that paid Union anti-dumping or countervailing duties on the importation of goods that were customs cleared in Northern Ireland in accordance with the above mentioned legislation made applicable in respect of Northern Ireland by the IE/NI Protocol may only ask for a refund of such duties pursuant to Article 11(8) of Regulation (EU) 2016/1036 or Article 21 of Regulation (EU) 2016/1037, respectively.

(1) Notice regarding the application of anti-dumping and anti-subsidy measures in force in the Union following the withdrawal of the United Kingdom and the possibility of a review (OJ C 18, 18.1.2021, p. 41).

(2) Read in conjunction with Annex 2, point 5 (‘Trade defence instruments’), of that Protocol.

(3) Article 185 of the Withdrawal Agreement.

(4) Article 18(5) of the IE/NI Protocol.

(5) Decision No 3/2020 of the Joint Committee established by the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 17 December 2020 (OJ L 443, 30.12.2020, p. 3).

(6) Decision No 4/2020 of the Joint Committee established by the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 17 December 2020 (OJ L 443, 30.12.2020, p. 6).
Official Journal of the European Union

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

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

(Text with EEA relevance)

(2021/C 269/04)
Explanatory Notes to the Combined Nomenclature of the European Union

(2021/C 333 I/04)

Pursuant to Article 9(1)(a) of Council Regulation (EEC) No 2658/87 (1), the Explanatory Notes to the Combined Nomenclature of the European Union (2) are hereby amended as follows:

On page 414:

9506

Articles and equipment for general physical exercise, gymnastics, athletics, other sports (including table tennis) or outdoor games, not specified or included elsewhere in this chapter; swimming pools and paddling pools

Delete and replace the current explanatory note by the following:

‘This heading does not include resistance bands, fitness bands or similar products, for example simple loops, without handles or any other similar additional element that makes them identifiable as articles for general physical exercise. These products are usually packed individually or in packs of two or more for retail sale. They are available in different colours and sizes and may have imprints. According to their objective characteristics, these bands or other similar products are not identifiable as articles for general physical exercise. Consequently, they are to be classified according to their constituent material, for example in heading 4008 as “strips of non-cellular rubber” (see also note 1 and note 9 to Chapter 40), in heading 4016 as “other articles of vulcanised rubber other than hard rubber” or in heading 6307 as “other made-up textile articles”. Examples of bands, fitness bands or similar products that are to be classified according to their constituent material: Rubber band (heading 4008 ) Rubber loop (heading 4016 ) Textile loop (heading 6307)’

(1) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

(2) OJ C 119, 29.3.2019, p. 1.
Notice of the impending expiry of certain anti-dumping measures

(2021/C 398/11)

1. As provided for in Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1), the Commission gives notice that, unless a review is initiated in accordance with the following procedure, the anti-dumping measures mentioned below will expire on the date mentioned in the table below.

2. Procedure

Union producers may submit a written request for a review. This request must contain sufficient evidence that the expiry of the measures would be likely to result in a continuation or recurrence of dumping and injury. Should the Commission decide to review the measures concerned, importers, exporters, representatives of the exporting country and Union producers will then be provided with the opportunity to amplify, rebut or comment on the matters set out in the review request.

3. Time limit

Union producers may submit a written request for a review on the above basis, to reach the European Commission, Directorate-General for Trade (Unit G-1), CHAR 4/39, 1049 Brussels, Belgium (2) at any time from the date of the publication of the present notice but no later than three months before the date mentioned in the table below.

4. This notice is published in accordance with Article 11(2) of Regulation (EU) 2016/1036. Product Country(ies) of origin or exportation Measures Reference Date of expiry (3) Certain coated fine paper The People’s Republic of China Anti-dumping duty Commission Implementing Regulation (EU) 2017/1188 of 3 July 2017 imposing a definitive anti-dumping duty on imports of certain coated fine paper originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of the Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 171, 4.7.2017, p. 168) 5.7.2022

(1) OJ L 176, 30.6.2016, p. 21.

(2) TRADE-Defence-Complaints@ec.europa.eu

(3) The measure expires at midnight (00:00) of the day mentioned in this column.
Official Journal of the European Union

Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community

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

(Text with EEA relevance)

(2021/C 430/09)
Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (1))

(Text with EEA relevance)

(2021/C 463/10)

Decision granting an authorisation

Reference of the decision (2) Date of decision Substance name Holder of the authorisation Authorisation number Authorised use Date of expiry of review period Reasons for the decision C(2021)7882 9 November 2021 4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO) EC No: -, CAS No:- Novo Nordisk A/S, Novo Alle, 2880 Bagsværd, Denmark REACH/21/11/0 As a solvent/detergent agent for virus inactivation in the manufacture of pharmaceutical products used in the treatment of rare bleeding disorders 4 January 2033 In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health from the uses of the substance and there are no suitable alternative substances or technologies.

(1) OJ L 396, 30.12.2006 , p. 1.

(2) The decision is available on the European Commission website at: Authorisation (europa.eu)
—

Fiktionsbescheinigung (Provisional residence document) Only if the third box on page 3 is ticked – the residence permit continues to be valid. Entry is allowed only in connection with an expired residence permit, visa, a valid passport pursuant to Article 10 of Directive 2004/38/EC, or a German permanent residence card pursuant to Article 20 of Directive 2004/38/EC. If the first or second box is ticked, the ‘Fiktionsbescheinigung’ does not entail the right of entry without a visa. Provision on the implementation of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community As provided for in the provisions concerning the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union, with effect from the end of the transition period under this Agreement, British nationals and their family members who hold rights in Germany under Part Two Title II Chapter 1 or under Article 24 (2), also in conjunction with Article 25 (2) of the Agreement, are allowed to enter even if they do not have an expired residence permit or a visa in addition to their passport also with a ‘Fiktionsbescheinigung’ (provisional residence document) in which the fourth box on page 3 is marked, indicating (In German) that ‘The holder has applied for documentation of a right of residence under the Freedom of Movement Act/EU or the EU-Switzerland Agreement, which is hereby provisionally certified’, even if they do not have an expired residence permit and a visa in addition to their passport. That indication in the document is written in German and reads: ‘Der Inhaber / die Inhaberin hat die Dokumentation eines Aufenthaltsrechts nach dem FreizügG/EU oder dem Abkommen EU-Schweiz beantragt, das hiermit vorläufig bescheinigt wird.’ The same box is marked if the holder already has applied for documentation of a right of residence under the Freedom of Movement Act/EU or the EU-Switzerland Agreement, but no document according to the uniform format defined by Council Regulation (EC) No 1030/2002 (4) is ready for issuance. In this case, the right of residence is certified by the provisional residence document. In such cases, holders of a Fiktionsbescheinigung are allowed to enter if the fourth box on page 3 of the document is marked, indicating that ‘The holder has applied for documentation of a right of residence under the Freedom of Movement Act/EU or the EU-Switzerland Agreement, which is hereby provisionally certified’, even if they do not have an expired residence permit or a visa in addition to their passport.
Corrigendum to Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community – Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations

( Official Journal of the European Union C 240 of 22 June 2022 )

(2022/C 262/14)

On page 19, section ‘Period of validity of the contract’

for:

‘From January 1st 2023 to December 31st 2023.’

read:
Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 February 2022

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 (1))

(2022/C 29/02)

Base rates calculated in accordance with the Communication from the Commission on the revision of the method for setting the reference and discount rates (OJ C 14, 19.1.2008, p. 6.). Depending on the use of the reference rate, the appropriate margins have still to be added as defined in this communication. For the discount rate this means that a margin of 100 basispoints has to be added. The Commission Regulation (EC) No 271/2008 of 30 January 2008 amending Regulation (EC) No 794/2004 foresees that, unless otherwise provided for in a specific decision, the recovery rate will also be calculated by adding 100 basispoints to the base rate.

Modified rates are indicated in bold.

Previous table published in OJ C 504, 14.12.2021, p. 47.

From To AT BE BG CY CZ DE DK EE EL ES FI FR HR HU IE IT LT LU LV MT NL PL PT RO SE SI SK UK 1.2.2022 … -0,49 -0,49 0,00 -0,49 3,29 -0,49 -0,03 -0,49 -0,49 -0,49 -0,49 -0,49 0,26 3,17 -0,49 -0,49 -0,49 -0,49 -0,49 -0,49 -0,49 2,04 -0,49 2,74 -0,05 -0,49 -0,49 0,66 1.1.2022 31.1.2022 -0,49 -0,49 0,00 -0,49 2,49 -0,49 -0,01 -0,49 -0,49 -0,49 -0,49 -0,49 0,26 2,38 -0,49 -0,49 -0,49 -0,49 -0,49 -0,49 -0,49 1,21 -0,49 2,27 -0,03 -0,49 -0,49 0,51

(1) OJ L 140, 30.4.2004, p. 1.
Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 28.1.2022 Paxlovid (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide / ritonavir Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/22/1625 Film-coated tablet Pending 28.1.2022

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact: