ddrg/super_eurlex huggingface dataset:
Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2018 to 31 December 2018

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

(2019/C 32/02)

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorization Member State concerned Date of notification 18.12.2018 Perlinring and associated names - etonogestrel/ethinylestradiol See annex See annex 19.12.2018

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

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

Winding-up proceedings

Decision to start winding-up proceedings in respect of Qudos Insurance A/S

(Publication made in accordance with Article 280 of Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II))

(2019/C 27/09)
Official Journal of the European Union

Communication on the publication of the amounts of raw milk production as referred to in Article 149(5) of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (1)

(2019/C 55/04)

Annual data (1000 t) Amounts of raw milk production (*2) as referred to in Article 149(5) of Regulation (EU) No 1308/2013 2017 Cow Ewe Goat Buffalo BE 4 031,00 0,00 34,00 0,00 BG 968,18 69,38 43,54 10,38 CZ 3 079,21 0,02 0,05 0,00 DK 5 502,20 0,00 0,00 0,00 DE 32 598,20 0,01 15,97 0,00 EE 790,00 0,00 0,60 0,00 IE 7 498,94 0,00 0,00 0,00 EL 670,00 806,00 331,00 0,00 ES 7 229,35 564,78 506,43 0,00 FR 25 007,64 303,91 631,71 0,00 HR 648,00 9,00 11,00 0,00 IT 12 198,88 480,08 61,28 242,99 CY 216,39 32,29 30,36 0,00 LV 998,00 0,00 2,10 0,00 LT 1 566,65 0,00 4,06 0,00 LU 387,18 0,09 3,18 0,00 HU 1 967,50 1,81 3,68 0,00 MT 41,03 0,86 0,00 0,00 NL 14 501,00 0,00 320,00 0,60 AT 3 712,73 11,98 23,08 0,00 PL 13 694,47 0,55 7,36 0,00 PT 1 921,21 73,77 25,79 0,00 RO 3 797,70 386,80 238,30 16,40 SI 647,99 0,50 1,48 0,00 SK 911,73 11,41 0,26 0,00 FI 2 405,76 0,00 0,00 0,00 SE 2 816,66 0,00 0,00 0,00 UK 15 443,00 6,76 (*3) 44,25 (*3) 0,00 EU-28 165 250,60 2 760,00 2 339,48 270,37

(1) OJ L 347, 20.12.2013, p. 671.

(*1) 0,0: zero or less than half the unit

(*2) 2017 Milk Production on the farm Eurostat — NewCronos Products Obtained.

(*3) Communicated by Member State and/or estimated/calculated production.
Official Journal of the European Union

Authorisation for State aid pursuant to Articles 107 and 108 of the Treaty on the Functioning of the European Union

Cases where the Commission raises no objections

(Text with EEA relevance, except for products falling under Annex I of the Treaty)

(2019/C 40/02)

Date of adoption of the decision 16.11.2018 Aid number SA.51683 (2018/N) Member State Germany Region BAYERN — Title (and/or name of the beneficiary) Bayern: Förderung von Maßnahmen zur Erhaltung gefährdeter einheimischer landwirtschaftlicher Nutztierrassen 2019 Legal basis Bayern: Förderung gefährdeter einheimischer Nutztierrassen 2019 Type of measure Scheme — Objective Aid for agri-environment-climate commitments Form of aid Direct grant Budget Overall budget: EUR 2.4 (in millions) Annual budget: EUR 0.8 (in millions) Intensity 100 % Duration (period) until 31.12.2021 Economic sectors Animal production Name and address of the granting authority Bayerische Landesanstalt für Landwirtschaft, Kompetenzzentrum Förderprogramme Heinrich-Rockstroh-Str. 10, 95615 Marktredwitz Other information —

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/competition/elojade/isef/index.cfm.
Notice of the expiry of certain anti-dumping measures

(2019/C 68/08)

Further to the publication of a notice of impending expiry (1) following which no duly substantiated request for a review was lodged, the Commission gives notice that the anti-dumping measure mentioned below will expire.

This notice is published in accordance with 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 (2).

Product Country of origin or exportation Measures Reference Date of expiry (3) Electrolytic manganese dioxides (i.e. manganese dioxides produced through an electrolytic process) not heat-treated after the electrolytic process, currently falling within CN code ex 2820 10 00 (TARIC code 2820100010 ) The Republic of South Africa Definitive anti-dumping duty Council Implementing Regulation (EU) No 191/2014 imposing a definitive anti-dumping duty on imports of certain manganese dioxides originating in the Republic of South Africa following an expiry review pursuant to Article 11(2) of Regulation (EC) No 1225/2009 (OJ L 59, 28.2.2014, p. 7) 1.3.2019

(1) OJ C 203, 13.6.2018, p. 17.

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

(3) The measure will expire at midnight of the day mentioned in this column.
Notice of the impending expiry of certain anti-dumping measures

(2019/C 104/06)

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 lodge 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 H-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 prepared or preserved citrus fruits (namely mandarins, etc.) The People’s Republic of China Anti-dumping duty Commission Implementing Regulation (EU) No 1313/2014 of 10 December 2014 imposing a definitive anti-dumping duty on imports of certain prepared or preserved citrus fruits (namely mandarins, etc.) originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Council Regulation (EC) no 1225/2009 (OJ L 354, 11.12.2014, p. 17). 12.12.2019

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

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

(3) The measure expires at midnight of the day mentioned in this column.
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)

(2019/C 89/05)

Decisions granting an authorisation

Reference of the decision (2) Date of decision Substance name Holder of the authorisation Authorisation numbers Authorised uses Date of expiry of review period Reasons for the decision C(2019) 1577 1 March 2019 1,2-dichloroethane EC No 203-458-1; CAS No 107-06-2 OLON Spa, Strada Rivoltana Km 6/7, 20090, Rodano, Milano, Italy REACH/19/1/0 Use as a solvent in the manufacturing of the active pharmaceutical ingredient epirubicin. 22 November 2029 In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socioeconomic benefits outweigh the risk to human health arising from the use of the substance and there are no suitable alternative substances or technologies in terms of their technical and economic feasibility for the applicant before the sunset date. REACH/19/1/1 Use as a solvent in the manufacturing of the active pharmaceutical ingredient prednisolone steaglate.

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

(2) The decision is available on the European Commission website at: http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm
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

Imposition of public service obligations in respect of scheduled air services

(Text with EEA relevance)

(2019/C 121/08)
Notice of the impending expiry of certain anti-dumping measures

(2019/C 165/05)

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 lodge 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 H-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 of the European Parliament and of the Council.

Product Country(ies) of origin or exportation Measures Reference Date of expiry (3) Monosodium glutamate Indonesia Anti-dumping duty Commission Implementing Regulation (EU) 2015/84 of 21 January 2015 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of monosodium glutamate originating in Indonesia (OJ L 15, 22.1.2015, p. 54) 23.1.2020

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

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

(3) The measure expires at midnight of the day mentioned in this column.
Communication from the Commission amending Communication 2012/C 72/07 — Guidelines for the deduction of quotas under Article 105(1), (2) and (5) of Regulation (EC) No 1224/2009

(2019/C 192/03)

Following the complete entry into force of the landing obligation set up by Article 15 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (1), the Communication from the Commission — Guidelines for the deduction of quotas under Article 105(1), (2) and (5) of Regulation (EC) No 1224/2009 (2) is amended as follows:

(1) point 3(b) is replaced by the following: ‘(b) where the stock concerned is caught in a mixed fishery and a significant loss of quota would prevent the exploitation of the associated species in that mixed fishery catch; or’;

(2) point 5 is deleted.

(1) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).

(2) OJ C 72, 10.3.2012, p. 27.
Explanatory Notes to the Combined Nomenclature of the European Union

(2019/C 179/02)

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 293, the following explanatory note is inserted:

‘7019 39 00 Other This subheading includes multi-axial glass fibre fabrics which consist of separate layers of parallel glass filament yarns and where the layers are laid on top of one another at different angles. The layers are bound together with a synthetic thread by mechanical bonding. These fabrics are used, for example, in boat and ship building or for making blades for wind turbines.’

(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.
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)

(2019/C 210/09)
COMMUNICATION FROM THE COMMISSION

Regarding the start of functioning of the Advisory Council for Outermost Regions

(2019/C 219/03)

Article 43(2) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (1) creates four new Advisory Councils, including one for Outermost Regions. The Advisory Councils for Aquaculture, for Markets and for the Black Sea were all set-up in 2016 (2). The Advisory Council for Outermost Regions is the last Advisory Council to be set-up.

In line with Article 3 of Commission Delegated Regulation (EU) 2015/242 of 9 October 2014 laying down detailed rules on the functioning of Advisory Councils under the Common Fisheries Policy (3), stakeholders interested in the setting up of this new Advisory Council have submitted to the Commission in January 2019, a joint application regarding the start of functioning of an Advisory Council for Outermost Regions.

The Commission has verified the compatibility of the joint application with the relevant EU rules and subsequently transmitted it to the three Member States concerned (4), who needed to determine whether the application is signed by representative sector organisations and other interest groups.

Member States concerned did not raise any objection within the deadline of one month set in Article 3(3) of Delegated Regulation (EU) 2015/242. In conclusion, the Advisory Council for Outermost Regions can start functioning and become eligible to receive an annual contribution from the EU Budget to cover a part of its operational costs from the day following the publication of this Communication in the Official Journal of the European Union.

(1) OJ L 354, 28.12.2013, p. 22.

(2) Communication from the Commission regarding the start of the functioning of the Advisory Council for Aquaculture, of the Advisory Council for Markets and of the Advisory Council for the Black Sea (OJ C 74, 26.2.2016, p. 1).

(3) OJ L 41, 17.2.2015, p. 1.

(4) France, Portugal, Spain.
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)

(2019/C 241/05)

Decisions 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(2019) 5022 10 July 2019 Chromium trioxide EC No. 215-607-8, CAS No. 1333-82-0 ZF Friedrichshafen AG, Bogestrasse 50, 53783 Eitorf, Germany REACH/19/25/0 Use for functional chrome plating of piston rods for automotive and rail applications 10 July 2031 In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health from the use 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: http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm
Explanatory Notes to the Combined Nomenclature of the European Union

(2019/C 248/03)

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 169, in the Explanatory Note to heading ‘3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale’, the following text is added:

‘This heading includes, inter alia, hormone, co-enzyme and co-factors preparations. These preparations are based on hormones of heading 2937, on enzyme co-factors and mixtures thereof. Such preparations contain a sufficient quantity of active substances to provide therapeutic or prophylactic effect against a specific disease or ailment. The daily dose is recommended on the label, packaging or on the accompanying user directions. The index of Anatomical Therapeutic Chemicals (WHO ATC-DDD index) (https://www.whocc.no/atc_ddd_index/), developed by the World Health Organisation (WHO), indicates the Defined Daily Dose (DDD) providing therapeutic or prophylactic effect when applied in quantities equal to or exceeding the amounts listed in that index. The following table shows the DDD for α-lipoic acid and melatonin: Name of the active substance Defined Daily Dose Unit Administration route α-lipoic acid or thioctic acid 0,6 g oral 0,6 g parenteral Melatonin 2 mg oral’

(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.
Official Journal of the European Union

List of entities that are to be treated as Non-Reporting Financial Institutions for the purposes of subparagraph B.1(c) of Section VIII of Annex I of Council Directive 2011/16/EU

(2019/C 296/03)
Communication pursuant to Article 37(2) of Regulation (EU) No 908/2014 concerning the composition of the Conciliation Body, instituted in the context of the clearance of accounts of EAGF and the EAFRD

(2019/C 316/06)

The composition of the Conciliation Body is as follows:
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)

(2019/C 364/07)

Decisions granting an authorisation

Reference of the decision (2) Date of decision Substance name Holders of the authorisation Authorisation numbers Authorised uses Date of expiry of review periods Reasons for the decision C(2019) 7447 22 October 2019 Sodium chromate EC No 231-889-5; CAS No 7775-11-3 Aviall Services Inc. Schillingweg 40, 2153PL, Nieuw-Vennep, Noord-Holland, The Netherlands REACH/19/32/0 Formulation of mixtures for sealing after anodising, chemical conversion coating, pickling and etching applications by the aerospace sector 21 September 2024 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. REACH/19/32/2 Sealing after anodising, chemical conversion coating, pickling and etching applications by the aerospace sector, where any of the following key functionalities or properties is necessary for the intended use: for the pickling/etching process — etch rate, intergranular attack/end grain pitting, surface contamination, fatigue testing, tensile testing, surface roughness, impact to shot peen compressive layer; and for the chemical conversion coating and sealing after anodising process — corrosion resistance, active corrosion inhibition, adhesion promotion, chemical resistance, layer thickness, electrical properties Wesco Aircraft EMEA Limited, Lawrence House, Riverside drive, BD19 4DH Cleckheaton West Yorkshire, United Kingdom REACH/19/32/1 Formulation of mixtures for sealing after anodising, chemical conversion coating, pickling and etching applications by the aerospace sector REACH/19/32/3 Sealing after anodising, chemical conversion coating, pickling and etching applications by the aerospace sector, where any of the following key functionalities or properties is necessary for the intended use: for the pickling/etching process - etch rate, intergranular attack/end grain pitting, surface contamination, fatigue testing, tensile testing, surface roughness, impact to shot peen compressive layer; and for the chemical conversion coating and sealing after anodising process — corrosion resistance, active corrosion inhibition, adhesion promotion, chemical resistance, layer thickness, electrical properties

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

(2) The decision is available on the European Commission website at: http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm
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)

(2019/C 373/05)

Decisions 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(2019) 7683 29 October 2019 Potassium dichromate EC No 231-906-6, CAS No 7778-50-9 Wesco Aircraft EMEA Limited, Lawrence House, Riverside drive, BD19 4DH Cleckheaton West Yorkshire, United Kingdom REACH/19/31/0 Sealing after anodizing applications by the aerospace sector where the key functionalities of corrosion resistance or corrosion inhibition are necessary for the intended use. 21 September 2024 In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socioeconomic 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: http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm