ddrg/super_eurlex huggingface dataset:
COUNCIL DECISION (EU) 2018/1536

of 9 October 2018

establishing the position to be taken on behalf of the European Union within the Committee on Government Procurement on the accession of Australia to the Revised Agreement on Government Procurement

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) On 2 June 2015, Australia applied for accession to the Revised Agreement on Government Procurement (‘the Revised GPA’).

(2) Australia's commitments on coverage are laid down in its final offer, as submitted to the Parties to the Revised GPA (‘the Parties’) on 7 March 2018.

(3) Although comprehensive, the offer by Australia does not provide full coverage. It is thus appropriate to introduce certain carve-outs specific to Australia to Union coverage. These specific carve-outs, as reflected in the Attachment to this Decision, will become part of the terms of accession to the Revised GPA for Australia and will be reflected in the decision adopted by the Committee on Government Procurement (‘the GPA Committee’) on Australia's accession.

(4) Australia's accession to the Revised GPA is expected to make a positive contribution to further opening of public procurement markets internationally.

(5) Article XXII(2) of the Revised GPA provides that any Member of the WTO may accede to the Revised GPA on terms to be agreed between that Member and the Parties, with such terms stated in a decision of the GPA Committee.

(6) It is therefore appropriate to establish the position to be taken on behalf of the Union within the GPA Committee in relation to the accession of Australia,

HAS ADOPTED THIS DECISION:

Article 1 The position to be taken on behalf of the Union within the Committee on Government Procurement shall be to approve the accession of Australia to the Revised Agreement on Government Procurement, subject to the specific terms of accession set out in the Attachment to this Decision.

Article 2 This Decision shall enter into force on the date of its adoption.
COUNCIL DECISION (EU) 2018/1676

of 15 October 2018

on the signing, on behalf of the European Union, of the Investment Protection Agreement between the European Union and its Member States, of the one part, and the Republic of Singapore, of the other part

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4), in conjunction with Article 218(5) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) On 23 April 2007, the Council authorised the Commission to negotiate a free trade agreement (FTA) with Member States of the Association of Southeast Asian Nations (ASEAN). That authorisation provided for the possibility of bilateral negotiations.

(2) On 22 December 2009, the Council authorised the Commission to pursue bilateral FTA negotiations with individual ASEAN Member States, starting with Singapore, which were to be conducted in accordance with the existing negotiating directives.

(3) On 12 September 2011, the Council authorised the Commission to extend the on-going negotiations with Singapore also to cover investment protection.

(4) The negotiations for an Investment Protection Agreement between the European Union and its Member States, of the one part, and the Republic of Singapore, of the other part (the Agreement) have been concluded and the Agreement should be signed on behalf of the Union, subject to the fulfilment of the procedures required for its conclusion at a later date,

HAS ADOPTED THIS DECISION:

Article 1 The signing on behalf of the Union of the Investment Protection Agreement between the European Union and its Member States, of the one part, and the Republic of Singapore, of the other part, is hereby authorised, subject to the conclusion of the said Agreement. (1)

Article 2 The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.

Article 3 This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 15 October 2018. For the Council The President E. KÖSTINGER

(1) The text of the Agreement will be published together with the decision on its conclusion.
—

Standard EN ISO 10993-1 2010: biological evaluation of medical devices – evaluation and testing within a risk management process The introduction to the standard states that ‘this approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, thus enabling a full evaluation to be made of the biological responses to each medical device, relevant to its safety in use’; that ‘biological testing is based upon, among other things, in vitro and ex vivo test methods and upon animal models’; that ‘it is not intended that ISO 10993 provide a rigid set of test methods, including pass/fail criteria’; that it must be used ‘taking into consideration all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience’. Point 4.4 of the standard states in particular that ‘the choice of tests and the data required in a biological evaluation, and their interpretation, shall take into account the chemical composition of the materials, including the conditions of exposure as well as the nature, degree, frequency and duration of exposure of the medical device or its constituents to the body, enabling the categorisation of devices to facilitate the selection of appropriate tests (…). The rigour necessary in the biological evaluation is principally determined by the nature, degree, duration and frequency of the exposure and the hazards identified for the material’. Point 6.1 of the standard states in particular that ‘the results of the risk assessment can lead to the conclusion that additional material characterization is necessary, for example, where the margin of safety is not considered adequate if the entire amount of a particular chemical were to leach out. In such cases, appropriate extraction testing, simulating clinical exposure, can be used to estimate the degree of clinical exposure to the chemical constituent’. Point 6.2.2 of the standard, concerning test descriptions, states in particular that ‘it is indispensable for testing that each device be considered on its own merits. Additional tests not indicated in the table [in Annex A] may be necessary’ (point 6.2.2.1), that ‘in vivo tests may be required to assess biodegradation of a material’ (point 6.2.2.13) and that ‘toxicokinetic studies shall be considered if (…) substantial quantities of potentially toxic or reactive degradation products and leachables are likely or known to be released from a medical device into the body during clinical use’ (6.2.2.14). Annex A (informative) of the standard, which includes a table describing the biological evaluation tests to be taken into consideration with regard to the nature and duration of contact with the human body, does not explicitly cover ingestible medical devices. It states that ‘Table A.1 is a framework for the development of an assessment programme and is not a checklist’ and that ‘In addition to the framework set out in Table A.1, the following [i.e. the tests to be carried out] should be considered based on a risk assessment (…)’.
COUNCIL DECISION

of 26 November 2018

adopting the Council’s position on draft amending budget No 6 of the European Union for the financial year 2018

(2018/C 430/01)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 314 thereof, in conjunction with the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof,

Having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (1), and in particular Article 44 thereof,

Whereas:

— the Union’s budget for the financial year 2018 was definitively adopted on 30 November 2017 (2),

— on 16 October 2018, the Commission submitted a proposal containing draft amending budget No 6 to the general budget for the financial year 2018,

— in order to allow the adoption of draft amending budget No 6 to the general budget for 2018 before the end of the year, the Council needs to proceed without delay. Therefore, it is justified to shorten, in accordance with Article 3(3) of the Council’s Rules of Procedure, the eight-week period for the information of national Parliaments laid down in Article 4 of Protocol No 1,

HAS DECIDED AS FOLLOWS:

Sole Article The Council’s position on draft amending budget No 6 of the European Union for the financial year 2018 was adopted on 26 November 2018. The full text can be accessed for consultation or downloading on the Council’s website: http://www.consilium.europa.eu/

Done at Brussels, 26 November 2018. For the Council The President J. BOGNER-STRAUSS

(1) OJ L 193, 30.7.2018, p. 1.

(2) OJ L 57, 28.2.2018, p. 1.
COUNCIL DECISION

of 11 December 2018

adopting the Council’s position on the second draft budget of the European Union for the financial year 2019

(2018/C 451/02)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 314(3) thereof, in conjunction with the Treaty establishing the European Atomic Energy Community and in particular Article 106a thereof,

Whereas:

(1) on 30 November 2018, the Commission submitted a proposal containing the second draft general budget of the European Union for the financial year 2019 (1),

(2) the Council examined the Commission proposal with a view to defining a position consistent, on the revenue side, with Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (2), and, on the expenditure side, with Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (3),

(3) given the need to adopt a Council position on the second draft budget as soon as possible with a view to a budget being definitively adopted before the beginning of the financial year 2019, thus ensuring the continuity of the Union’s action, it is justified to shorten, in accordance with Article 3(3) of the Council’s Rules of Procedure, the eight-week period for the information of National Parliaments, as well as the ten-day period foreseen for placing the item on the Council’s provisional agenda laid down in Article 4 of Protocol No 1.

HAS DECIDED AS FOLLOWS:

Sole Article The Council’s position on the second draft general budget of the European Union for the financial year 2019 was adopted by the Council on 11 December 2018. The full text can be accessed for consultation or downloading on the Council’s website: http://www.consilium.europa.eu/

Done at Brussels, 11 December 2018. For the Council The President G. BLÜMEL

(1) COM(2018) 900 final.

(2) OJ L 168, 7.6.2014, p. 105.

(3) OJ L 347, 20.12.2013, p. 884.
COUNCIL DECISION (EU) 2018/2059

of 29 November 2018

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning the amendment of Annex IX (Financial Services) to the EEA Agreement

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.

(2) Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex IX to that Agreement, which contains provisions on financial services.

(3) Regulation (EU) 2015/847 of the European Parliament and of the Council (3) is to be incorporated into the EEA Agreement.

(4) Directive (EU) 2015/849 of the European Parliament and of the Council (4) is to be incorporated into the EEA Agreement.

(5) Commission Delegated Regulation (EU) 2016/1675 (5) is to be incorporated into the EEA Agreement.

(6) Annex IX to the EEA Agreement should therefore be amended accordingly.

(7) The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decisions,

HAS ADOPTED THIS DECISION:

Article 1 The position to be adopted, on behalf of the Union, within the EEA Joint Committee on the proposed amendment of Annex IX (Financial Services) to the EEA Agreement, shall be based on the draft decisions of the EEA Joint Committee attached to this Decision.

Article 2 This Decision shall enter into force on the date of its adoption.

Done at Brussels, 29 November 2018. For the Council The President M. SCHRAMBÖCK

(1) OJ L 305, 30.11.1994, p. 6.

(2) OJ L 1, 3.1.1994, p. 3.

(3) Regulation (EU) 2015/847 of the European Parliament and of the Council of 20 May 2015 on information accompanying transfers of funds and repealing Regulation (EC) No 1781/2006 (OJ L 141, 5.6.2015, p. 1).

(4) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73).

(5) Commission Delegated Regulation (EU) 2016/1675 of 14 July 2016 supplementing Directive (EU) 2015/849 of the European Parliament and of the Council by identifying high-risk third countries with strategic deficiencies (OJ L 254, 20.9.2016, p. 1).
EN Official Journal of the European Union L 84/18

DECISION (EU) 2018/514 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 14 March 2018

on the mobilisation of the European Globalisation Adjustment Fund following an application from Sweden — EGF/2017/007 SE/Ericsson

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1309/2013 of the European Parliament and of the Council of 17 December 2013 on the European Globalisation Adjustment Fund (2014-2020) and repealing Regulation (EC) No 1927/2006 (1), and in particular Article 15(4) thereof,

Having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (2), and in particular point 13 thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) The European Globalisation Adjustment Fund (EGF) aims to provide support for workers made redundant and self-employed persons whose activity has ceased as a result of major structural changes in world trade patterns due to globalisation, as a result of a continuation of the global financial and economic crisis, or as a result of a new global financial and economic crisis, and to assist them with their reintegration into the labour market.

(2) The EGF is not to exceed a maximum annual amount of EUR 150 million (2011 prices), as laid down in Article 12 of Council Regulation (EU, Euratom) No 1311/2013 (3).

(3) On 9 August 2017, Sweden submitted an application to mobilise the EGF, in respect of redundancies in Ericsson (Telefonaktiebolaget LM Ericsson) in Sweden. It was supplemented by additional information provided in accordance with Article 8(3) of Regulation (EU) No 1309/2013. That application complies with the requirements for determining a financial contribution from the EGF as laid down in Article 13 of Regulation (EU) No 1309/2013.

(4) The EGF should, therefore, be mobilised in order to provide a financial contribution of EUR 2 130 400 in respect of the application submitted by Sweden.

(5) In order to minimise the time taken to mobilise the EGF, this decision should apply from the date of its adoption,

HAVE ADOPTED THIS DECISION:

Article 1

For the general budget of the Union for the financial year 2018, the European Globalisation Adjustment Fund shall be mobilised to provide the amount of EUR 2 130 400 in commitment and payment appropriations.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply from 14 March 2018.

Done at Strasbourg, 14 March 2018. For the European Parliament The President A. TAJANI For the Council The President L. PAVLOVA

(1) OJ L 347, 20.12.2013, p. 855.

(2) OJ C 373, 20.12.2013, p. 1.

(3) Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, p. 884).
Official Journal of the European Union

DECISION (EU) 2019/323 OF THE EUROPEAN CENTRAL BANK

of 12 February 2019

nominating heads of work units to adopt delegated decisions regarding supervisory powers granted under national law (ECB/2019/5)

THE EXECUTIVE BOARD OF THE EUROPEAN CENTRAL BANK,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to the Statute of the European System of Central Banks and of the European Central Bank, and in particular Article 11.6 thereof,

Having regard to Decision (EU) 2017/933 of the European Central Bank of 16 November 2016 on a general framework for delegating decision-making powers for legal instruments related to supervisory tasks (ECB/2016/40) (1), and in particular Articles 4 and 5 thereof,

Having regard to Decision (EU) 2019/322 of the European Central Bank of 31 January 2019 on the delegation of the power to adopt decisions regarding supervisory powers granted under national law (ECB/2019/4) (2), and in particular Article 3 thereof,

Having regard to Decision ECB/2004/2 of 19 February 2004 adopting the Rules of Procedure of the European Central Bank (3), and in particular Article 10 thereof,

Whereas:

(1) To address the considerable number of decisions that the European Central Bank (ECB) is to adopt for the performance of its supervisory tasks, a procedure for the adoption of specific delegated decisions has been established.

(2) A delegation decision is effective upon the adoption of a decision by the Executive Board nominating one or more heads of work units to take decisions on the basis of a delegation decision.

(3) The importance of the delegation decision and the number of addressees to whom delegated decisions need to be sent should be taken into account by the Executive Board in nominating heads of work units.

(4) The Chair of the Supervisory Board has been consulted on the heads of work units to whom the power to adopt decisions regarding supervisory powers granted under national law should be delegated,

HAS ADOPTED THIS DECISION:

Article 1 Delegated decisions regarding supervisory powers granted under national law Delegated decisions pursuant to Decision (EU) 2019/322 (ECB/2019/4) shall be adopted by one of the following heads of work units: (a) the Director-General of Directorate-General Microprudential Supervision I, if supervision of the relevant supervised entity or group is carried out by Directorate-General Microprudential Supervision I; (b) the Director-General of Directorate-General Microprudential Supervision II, if supervision of the relevant supervised entity or group is carried out by Directorate-General Microprudential Supervision II; or (c) if a Director-General is unavailable, their Deputy Director-General.

Article 2 Entry into force This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Frankfurt am Main, 12 February 2019. The President of the ECB Mario DRAGHI

(1) OJ L 141, 1.6.2017, p. 14.

(2) See page 7 of this Official Journal.

(3) OJ L 80, 18.3.2004, p. 33.
COUNCIL DECISION (EU) 2019/375

of 5 March 2019

appointing a member, proposed by the Italian Republic, of the Committee of the Regions

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 305 thereof,

Having regard to the proposal of the Italian Government,

Whereas:

(1) On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020. On 11 July 2017, by Council Decision (EU) 2017/1334 (4), Mr Augusto ROLLANDIN was replaced by Mr Pierluigi MARQUIS as a member. On 29 January 2018, by Council Decision (EU) 2018/157 (5), Mr Pierluigi MARQUIS was replaced by Mr Laurent VIERIN as a member. On 8 October 2018, by Council Decision (EU) 2018/1510 (6), Mr Laurent VIERIN was replaced by Ms Nicoletta SPELGATTI as a member.

(2) A member's seat on the Committee of the Regions has become vacant following the end of the term of office of Ms Nicoletta SPELGATTI,

HAS ADOPTED THIS DECISION:

Article 1 The following is hereby appointed as a member of the Committee of the Regions for the remainder of the current term of office, which runs until 25 January 2020: — Mr Pierluigi MARQUIS, Consigliere della Regione Autonoma Valle d'Aosta.

Article 2 This Decision shall enter into force on the date of its adoption.

Done at Brussels, 5 March 2019. For the Council The President G.L. GAVRILESCU

(1) Council Decision (EU) 2015/116 of 26 January 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 20, 27.1.2015, p. 42).

(2) Council Decision (EU) 2015/190 of 5 February 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 31, 7.2.2015, p. 25).

(3) Council Decision (EU) 2015/994 of 23 June 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 159, 25.6.2015, p. 70).

(4) Council Decision (EU) 2017/1334 of 11 July 2017 appointing a member, proposed by the Italian Republic, of the Committee of the Regions (OJ L 185, 18.7.2017, p. 45).

(5) Council Decision (EU) 2018/157 of 29 January 2018 appointing a member, proposed by the Italian Republic, of the Committee of the Regions (OJ L 29, 1.2.2018, p. 35).

(6) Council Decision (EU) 2018/1510 of 8 October 2018 appointing two members, proposed by the Italian Republic, of the Committee of the Regions (OJ L 255, 11.10.2018, p. 15).