ddrg/super_eurlex huggingface dataset:
EN Official Journal of the European Union C 490/13

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2016 to 29 February 2016

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2016/C 490/03)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 11.2.2016 Solumarv Marvel Lifesciences Limited Congress House Lyon Road HA1 2EN Harrow United Kingdom — 15.2.2016

— Modification of a marketing authorization (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 Holder of the marketing authorization Number of the entry in the Community Register Date of notification 11.2.2016 Tybost Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/872 7.3.2016 26.2.2016 Clopidogrel Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/08/465 1.3.2016

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

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

(1) OJ L 136, 30.4.2004, p. 1.
EN Official Journal of the European Union C 189/54

Corrigendum to Winding-up proceedings — Decision to open winding-up proceedings in respect of ADRIA Way

( Official Journal of the European Union C 123 of 20 April 2017 )

(2017/C 189/18)

On page 3, in the title, after ‘Insurance undertaking’ and after ‘Date, entry into force and nature of the decision’:

for:

‘ADRIA Way’,

read:
Official Journal of the European Union

Corrigendum to the publication of an amendment application pursuant to Article 17(6) of Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89

( Official Journal of the European Union C 317 of 23 September 2017 )

(2019/C 69/06)

On page 8, point 7, fourth paragraph:

for:

‘The ageing area is situated at altitudes of over 2 400 meters.’

read:
EN Official Journal of the European Union C 25/3

Commission Communication 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

Establishment of public service obligations in respect of scheduled air services for air cargo and mail

(2017/C 25/03)
Date, nature of the decision and date of entry into force

Decision No 207/2/29.11.2016 of the Credit and Insurance Committee of the Bank of Greece concerning:

the extension of the suspension of payments and disbursements by the insurance undertaking until 16 January 2017, as imposed by Decision No 185/1/12.5.2016.

Entry into force: as of the adoption date (29.11.2016)

End of validity:
EN Official Journal of the European Union C 48/7

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)

(2017/C 48/08)

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(2017) 661 8 February 2017 Sodium dichromate EC No 234-190-3, CAS No 7789-12-0 10588-01-9 Boliden Mineral AB, Rönnskärsverken, 932 81, Skelleftehamn, Sweden REACH/17/4/0 Use of sodium dichromate in copper/lead separation in concentrators handling complex sulphide ores 21 September 2024 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 economic feasibility.

(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
EN Official Journal of the European Union C 81/4

Information communicated by Member States regarding closure of fisheries

(2017/C 81/04)

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 27.1.2017 Duration 27.1.2017-31.12.2017 Member State Belgium Stock or Group of stocks RJU/07-D Species Undulate ray (Raja undulata) Zone Union waters of VIId Type(s) of fishing vessels — Reference number 02/TQ127

(1) OJ L 343, 22.12.2009, p. 1.
‘9021 10 10

Orthopaedic appliances This subheading includes “orthopaedic appliances” which are specially designed for a particular orthopaedic purpose, in distinction to ordinary products that might be used for different purposes (for example, products for overstrained joints, ligaments or tendons caused by sporting activities, type writing, and products which simply alleviate pain in the defective or disabled part of the body, for example, caused by inflammation). The “orthopaedic appliances” must completely prevent a specific movement of the defective or disabled part of the body (for example, joints, ligaments or tendons) in order to exclude further injuries or (an aggravation of) bodily deformities as distinct from ordinary products that allow undesired movements, yet avoid reflex movements (i.e. movements carried out subconsciously) through their relative inflexibility caused by, for example, flexible splints, pressure pads, non-elastic textile materials, restrictions through “Velcro-type” straps. See also Note 6 to Chapter 90 and the judgment in Joined Cases C-260/00 to C-263/00, Lohmann GmbH & Co. KG and Medi Bayreuth Weihermüller & Voigtmann GmbH & Co. KG v Oberfinanzdirektion Koblenz, paragraphs 36, 37, 39, 40, 43 and 45, (ECLI:EU:C:2002:637). Examples of products falling under subheading 9021 10 10: Examples of products falling under Section XI: ’
EN Official Journal of the European Union C 127/1

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)

(2017/C 127/01)

Date of adoption of the decision 24.11.2016 Aid number SA.43414 (2016/N) Member State Romania Region — — Title (and/or name of the beneficiary) Închiderea unor mine de cărbune în România Legal basis — Type of measure Scheme Complexul Energetic Hunedoara SA Objective Closure aid Form of aid Direct grant/Interest rate subsidy Budget Overall budget: RON 447,862 (in millions) Intensity % Duration (period) 01.11.2016 — 31.12.2024 Economic sectors MINING AND QUARRYING Name and address of the granting authority Ministerul Energiei Splaiul Independenței 202E, București, Romania 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.

Date of adoption of the decision 05.10.2016 Aid number SA.46066 (2016/N) Member State Croatia Region — — Title (and/or name of the beneficiary) Resolution scheme for small credit institutions with total assets below EUR 1,5 billion Legal basis Croatian Resolution Act for credit institutions and investment companies (ZOSI) Type of measure Scheme — Objective Remedy for a serious disturbance in the economy Form of aid Direct grant Budget — Intensity Measure does not constitute aid Duration (period) — Economic sectors Financial service activities; except insurance and pension funding Name and address of the granting authority STATE AGENCY FOR DEPOSIT INSURANCE AND BANK REHABILITATION (DAB) Jurišićeva 1/II, 10000 Zagreb, Croatia 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.

Date of adoption of the decision 17.03.2017 Aid number SA.47351 (2017/N) Member State United Kingdom Region SCOTLAND — Title (and/or name of the beneficiary) Prolongation of the State aid Scheme SA.43564 ‘Scottish Green Bus Fund’ Legal basis Section 5 of the Science and Technology Act 1965 Type of measure Scheme — Objective Environmental protection Form of aid Direct grant Budget Overall budget: GBP 3 (in millions) Annual budget: GBP 3 (in millions) Intensity 80 % Duration (period) until 31.12.2018 Economic sectors Other passenger land transport n.e.c. Name and address of the granting authority Tom Davy Transport Scotland, Area 2D North, Victoria Quay, The Shore, Edinburgh, EH66QQ, Scotland. 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.
EN Official Journal of the European Union C 145/8

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)

(2017/C 145/09)
(40)

The analysis of bidding data for the Large segment indicates that GE and Alstom are close competitors for the following reasons: (i) after Siemens, Alstom is the firm that participates the most often against GE, both at the firm stage and at the shortlist stage of a tender; (ii) MHPS and Ansaldo have more limited competitive interactions with GE than Alstom, both at the firm stage and at the shortlist stage, (iii) GE and Alstom compete against one another in a significant share of competitive tenders ([CONFIDENTIAL]), (iv) tenders where the Parties compete against one another have a concentrated market structure, with a significant proportion of tenders with three participants or fewer, (v) Alstom appears as the second most important competitive constraint on GE's probability of winning a tender (after Siemens), whilst this is less the case for MHPS, and even less the case for Ansaldo, (vi) GE's margins are negatively correlated with Alstom's participations, (vii) GE participates in many tenders against Alstom, and GE's accounts for a significant share of Alstom's losses, suggesting that GE is also a competitive constraint to Alstom. This evidence therefore indicates the presence of significant horizontal unilateral effects from the transaction.
EN Official Journal of the European Union C 159/1

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)

(2017/C 159/01)

Date of adoption of the decision 01.09.2015 Aid number SA.38406 (2014/N) Member State Croatia Region HRVATSKA — Title (and/or name of the beneficiary) Program državnih potpora za proizvodnju električne energije iz obnovljivih izvora energije Legal basis Strategija energetskog razvitka Republike Hrvatske; Zakon o energiji; Zakon o tržištu električne energije; Pravilnik o stjecanju statusa povlaštenog proizvođača električne energije; Tarifni sustav za proizvodnju električne energije iz obnovljivih izvora energije i kogeneracije; Metodologija za određivanje iznosa tarifnih stavki za opskrbu električnom energijom u okviru univerzalne usluge Type of measure Scheme — Objective Environmental protection, Sectoral development Form of aid Other — feed-in tariff. Budget Overall budget: HRK 2 314 (in millions) Annual budget: HRK 1 157 (in millions) Intensity 100 % Duration (period) 01.01.2014 — 31.12.2015 Economic sectors Production of electricity Name and address of the granting authority Ministarstvo gospodarstva Ulica grada Vukovara 78, 10000 Zagreb, Republika Hrvatska Hrvatski operator tržišta energije d.o.o. Miramarska 23, 10000 Zagreb, Republika Hrvatska 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.
EN Official Journal of the European Union C 174/4

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)

(2017/C 174/05)

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(2017) 3237 22 May 2017 Ammonium dichromate EC No 232-143-1 CAS No 7789-09-5 Micrometal GmbH, Renkenrusstrasse 24, 79639 Müllheim, Germany REACH/17/13/0 Use as photosensitiser for the production of micro components 21 September 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.

(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
1.

Council Decision (CFSP) 2016/849 (1) calls upon the Union to freeze the funds and economic resources of persons and entities, as referred to in the list drawn up in Annex II of Decision (CFSP) 2016/849. The Decision also calls upon the Member States to take the necessary measures to prevent the entry into, or transit through their territories of those same persons. The list drawn up by the Council of the EU comprises persons or entities responsible for the DPRK’s nuclear-related, ballistic missile-related or other weapons of mass destruction-related programmes, persons or entities acting on their behalf or at their direction, and entities owned or controlled by them, as well as persons or entities providing financial services or the transfer to, through or from the territory of the Union, or involving nationals of Member States or entities organised under their laws, or persons or financial institutions in the territory of the Union, of any financial or other assets or resources that could contribute to DPRK’s nuclear-related, other weapons of mass destruction-related or ballistic missile-related programmes, or persons, entities or bodies acting on their behalf or at their direction, or persons, entities or bodies owned or controlled by them.
EN Official Journal of the European Union C 180/34

Explanatory notes to the Combined Nomenclature of the European Union

(2017/C 180/06)

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, after the explanatory note to CN subheading ‘3504 00 10 Concentrated milk proteins specified in additional note 1 to this chapter’, the following text is inserted:

‘3504 00 90 Other This subheading includes plant-based products with a high protein content of more than 85 % by weight calculated on the dry matter. Products which are excluded are generally classified under headings 2106 or 2309.’

(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 76, 4.3.2015, p. 1.
EN Official Journal of the European Union C 188/5

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)

(2017/C 188/05)

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(2017) 3801 7 June 2017 Sodium dichromate EC No 234-190-3 CAS No 7789-12-0 10588-01-9 Electroquimica De Hernani S.A., Epele 20120, Hernani, Spain REACH/17/15/0 Use of sodium dichromate as an additive for supressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide or sodium chlorite 21 September 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

(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
EN Official Journal of the European Union C 205/55

Explanatory notes to the Combined Nomenclature of the European Union

(2017/C 205/06)

Pursuant to the second indent of 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 381, ‘9503 00 10 Tricycles, scooters, pedal cars and similar wheeled toys; dolls’ carriages’, the following text is inserted after the existing text:

‘This subheading also includes scooters fitted with an auxiliary motor, provided that the following limits are not exceeded:

— a speed not exceeding 20 km per hour,

— a net weight not exceeding 12 kg,

— one-speed transmission,

— only one hand brake or a foot brake on the rear wheel.

Whenever one of the above criteria is not met, scooters fitted with an auxiliary motor must be classified in heading 8711.’

(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 76, 4.3.2015, p. 1.
EN Official Journal of the European Union C 218/19

Update of the list of national services responsible for border controls as referred to in Article 16(2) of Regulation (EU) 2016/399 of the European Parliament and of the Council on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (1)

(2017/C 218/10)

The publication of the list of national services responsible for border controls as referred to in Article 16(2) of Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (2) is based on the information communicated by the Member States to the Commission in conformity with Article 39 of the Schengen Borders Code.

In addition to the publication in the Official Journal, a regular update is available on the website of the Directorate-General for Migration and Home Affairs.

GREECE

Replacement of the information published in OJ C 360, 10.12.2013.

The national service responsible for border controls: Ελληνική Αστυνομία (Helliniki Astynomia — Hellenic Police), Λιμενικό Σώμα (Limeniko Soma — Hellenic Coast Guard), Τελωνεία (Telonia — Customs), Πολεμικό Ναυτικό (Polemiko Naytiko — Hellenic Navy).

List of previous publications

(1) See the list of previous publications at the end of this update.

(2) OJ L 77, 23.3.2016, p. 1.
EN Official Journal of the European Union C 222/5

Commission notice on current State aid recovery interest rates and reference/discount rates for 28 Member States applicable as from 1 August 2017

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1))

(2017/C 222/07)

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 154, 17.5.2017, p. 27.
EN Official Journal of the European Union C 252/10

Commission communication 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)

(2017/C 252/06)
The UN Security Council adopted Resolution 2371(2017), adding the natural persons CHOE CHUN YONG (alias Ch’oe Ch’un-yo’ng), HAN JANG SU (alias Chang-Su Han), JANG SONG CHOL, JANG SUNG NAM, JO CHOL SONG (alias Cho Ch’o’l-so’ng), KANG CHOL SU, KIM MUN CHOL (alias Kim Mun-ch’o’l), KIM NAM UNG, PAK IL KYU (alias Pak Il-Gyu), and the entities FOREIGN TRADE BANK (FTB), KOREAN NATIONAL INSURANCE COMPANY (KNIC) (alias Korea Foreign Insurance Company), KORYO CREDIT DEVELOPMENT BANK (alias Daesong Credit Development Bank; Koryo Global Credit Bank; Koryo Global Trust Bank), MANSUDAE OVERSEAS PROJECT GROUP OF COMPANIES (alias Mansudae Art Studio) to the Sanctions Committee’s list.

In addition, the Security Council amended the listing of the natural persons JANG BOM SU (alias Jang Pom Su, Jang Hyon U) and JON MYONG GUK (alias Cho’n Myo’ng-kuk, Jon Yong Sang).

Those concerned may submit at any time a request to the United Nations Security Council Committee established pursuant to resolution 1718 (2006), together with any supporting documentation, for the decisions to include them in the UN list to be reconsidered. Such request should be sent to the following address:

United Nations – Focal point for delisting Security Council Subsidiary Organs Branch Room S-3055 E New York, NY 10017 UNITED STATES OF AMERICA

See for more information at: https://www.un.org/sc/suborg/en/sanctions/delisting
EN Official Journal of the European Union C 264/12

Information communicated by Member States regarding closure of fisheries

(2017/C 264/09)

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 1.7.2017 Duration 1.7.2017-31.12.2017 Member State Denmark Stock or Group of stocks LIN/3A/BCD Species Ling (Molva molva) Zone IIIa; Union waters of IIIbcd Type(s) of fishing vessels — Reference number 10/TQ127

(1) OJ L 343, 22.12.2009, p. 1.