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

DECISION OF THE EEA JOINT COMMITTEE

No 22/2017

of 3 February 2017

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2018/1756]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2016/576 of 14 April 2016 amending Regulation (EU) No 37/2010 as regards the substance ‘rafoxanide’ (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1 The following indent is added in point 13 (Commission Regulation (EU) No 37/2010) of Chapter XIII of Annex II to the EEA Agreement: ‘— 32016 R 0576: Commission Implementing Regulation (EU) 2016/576 of 14 April 2016 (OJ L 99, 15.4.2016, p. 1).’

Article 2 The text of Implementing Regulation (EU) 2016/576 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3 This Decision shall enter into force on 4 February 2017, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).

Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 3 February 2017. For the EEA Joint Committee The President Claude MAERTEN

(1) OJ L 99, 15.4.2016, p. 1.

(*1) No constitutional requirements indicated.
DECISION OF THE EEA JOINT COMMITTEE

No 27/2017

of 3 February 2017

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2018/1761]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Regulation (EU) 2016/2235 of 12 December 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bisphenol A (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1 The following indent is added in point 12zc (Regulation (EC) No 1907/2006 of the European Parliament and of the Council) of Chapter XV of Annex II to the EEA Agreement: ‘— 32016 R 2235: Commission Regulation (EU) 2016/2235 of 12 December 2016 (OJ L 337, 13.12.2016, p. 3).’

Article 2 The text of Regulation (EU) 2016/2235 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3 This Decision shall enter into force on 4 February 2017, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).

Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 3 February 2017. For the EEA Joint Committee The President Claude MAERTEN

(1) OJ L 337, 13.12.2016, p. 3.

(*1) No constitutional requirements indicated.
DECISION OF THE EEA JOINT COMMITTEE

No 58/2017

of 17 March 2017

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2018/1822]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2017/1 of 3 January 2017 on procedures for watercraft identification under Directive 2013/53/EU of the European Parliament and of the Council on recreational craft and personal watercraft (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1 The following point is inserted after point 2 (Directive 2013/53/EU of the European Parliament and of the Council) of Chapter XXXI of Annex II to the EEA Agreement: ‘3. 32017 R 0001 : Commission Implementing Regulation (EU) 2017/1 of 3 January 2017 on procedures for watercraft identification under Directive 2013/53/EU of the European Parliament and of the Council on recreational craft and personal watercraft ( : Commission Implementing Regulation (EU) 2017/1 of 3 January 2017 on procedures for watercraft identification under Directive 2013/53/EU of the European Parliament and of the Council on recreational craft and personal watercraft ( OJ L 1, 4.1.2017, p. 1 ).’

Article 2 The text of Implementing Regulation (EU) 2017/1 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3 This Decision shall enter into force on 18 March 2017, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).

Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 17 March 2017. For the EEA Joint Committee The President Claude MAERTEN

(1) OJ L 1, 4.1.2017, p. 1.

(*1) No constitutional requirements indicated.
DECISION OF THE EEA JOINT COMMITTEE

No 47/2017

of 17 March 2017

amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement [2018/1811]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

Commission Implementing Decision (EU) 2016/1898 of 26 October 2016 amending Implementing Decision 2013/764/EU concerning animal health control measures relating to classical swine fever in certain Member States (1) is to be incorporated into the EEA Agreement.

This Decision concerns legislation regarding live animals other than fish and aquaculture animals and animal products such as ova, embryo and semen. Legislation concerning these matters shall not apply to Iceland, as specified in paragraph 2 of the Introductory Part of Chapter I of Annex I to the EEA Agreement. This Decision is therefore not to apply to Iceland.

This Decision concerns legislation regarding veterinary matters. Legislation regarding veterinary matters shall not apply to Liechtenstein as long as the application of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein, as specified in the sectoral adaptations to Annex I to the EEA Agreement. This Decision is therefore not to apply to Liechtenstein.

Annex I to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Under the heading ‘ACTS OF WHICH THE EFTA STATES AND THE EFTA SURVEILLANCE AUTHORITY SHALL TAKE DUE ACCOUNT’ the following is added in point 48 (Commission Implementing Decision 2013/764/EU) in Part 3.2 of Chapter I of Annex I to the EEA Agreement:

‘, as amended by:

— 32016 D 1898: Commission Implementing Decision (EU) 2016/1898 of 26 October 2016 (OJ L 293, 28.10.2016, p. 39).

This act shall not apply to Iceland.’
Official Journal of the European Union

DECISION No 2/JP/2018

of 17 July 2018

of the Joint Committee established under the Agreement on Mutual Recognition between the European Community and Japan [2018/1104]





Having regard to the Agreement on Mutual Recognition between the European Community and Japan (hereinafter ‘Agreement’) and in particular paragraph 3 of Article 8 thereof;

Whereas the Joint Committee is to confirm the operational product scope of the Sectoral Annex on Good Manufacturing Practice for Medicinal Products (hereinafter ‘Sectoral Annex’), established by the Sub-committee under the Sectoral Annex in its 6th Meeting;

HAS DECIDED AS FOLLOWS:

1. The new operational scope of the categories of medicinal products subject to the Sectoral Annex of this Agreement, done at Brussels on April 4, 2001 now includes the following categories: (1) Chemical pharmaceuticals; (2) Homeopathic medicinal products (as long as treated as medicinal products and subject to the GMP requirements in Japan); (3) Vitamins, minerals and herbal medicines (if considered as medicinal products in both Parties); (4) Biological pharmaceuticals (1), including immunologicals and vaccines, belonging to the following categories; (4.1) Medicinal products produced by cell culture utilising natural microorganisms or established cell lines; (4.2) Medicinal products produced by cell culture utilising recombinant microorganisms or established cell lines; and (4.3) Medicinal products derived from non-transgenic plants and non-transgenic animals; (5) Active pharmaceutical ingredients (APIs) for any of the above categories; and (6) Sterile products belonging to any of the above categories.

2. This Decision, done in duplicate, shall be signed by the co-chairs. The Decision shall be effective from the date of the later of these signatures.

Signed in Tokyo, 17 July 2018. On behalf of Japan Daisuke OKABE Signed in Brussels, 28 June 2018. On behalf of the European Community Ignacio IRUARRIZAGA

(1) For the purpose of the Sectoral Annex on GMP, biological pharmaceuticals include products which are not necessarily designated by the Ministry of Health, Labour and Welfare as ‘biological products’ in accordance with laws and regulations of Japan but which would be considered as biological products in the EU.
EN Official Journal of the European Union L 1/3

DECISION No 1/2017 OF THE EU-GEORGIA ASSOCIATION COMMITTEE IN TRADE CONFIGURATION

of 6 December 2017

establishing the list of arbitrators referred to in Article 268(1) of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other part [2018/2]

THE ASSOCIATION COMMITTEE IN TRADE CONFIGURATION,

Having regard to the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other part (‘the Agreement’), and in particular Article 268(1) thereof,

Whereas:

(1) In accordance with Article 431 of the Agreement, parts of the Agreement have been applied provisionally since 1 September 2014.

(2) Pursuant to Article 408(3) of the Agreement, the Association Committee has the power to adopt decisions as provided for in the Agreement.

(3) Pursuant to Article 268(1) of the Agreement, the Association Committee in Trade configuration, as set out in Article 408(4) of the Agreement, is to establish a list of at least 15 individuals who are willing and able to serve as arbitrators in dispute settlement proceedings within six months of the start of the provisional application of the Agreement,

HAS ADOPTED THIS DECISION:

Article 1

The list of arbitrators for the purposes of Article 268(1) of the Agreement is established as set out in the Annex.

Article 2

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

Done at Tbilisi, 6 December 2017. For the Association Committee in Trade configuration The Chair G. ARVELADZE Secretaries M. GABUNIA S. ZALESKI
Corrigendum to Decision No 1/2018 of the ECAA Joint Committee of 3 May 2018 with regard to the adoption of its rules of procedure 2019/1802

( Official Journal of the European Union L 274 of 28 October 2019 )

On page 15:

for:

‘(*) This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.’,

read:
2.

The following points are inserted after point 47 (Regulation (EU) 2015/758 of the European Parliament and of the Council): ‘48. 32017 R 0078: Commission Implementing Regulation (EU) 2017/78 of 15 July 2016 establishing administrative provisions for the EC type-approval of motor vehicles with respect to their 112-based eCall in-vehicle systems and uniform conditions for the implementation of Regulation (EU) 2015/758 of the European Parliament and of the Council with regard to the privacy and data protection of users of such systems (OJ L 12, 17.1.2017, p. 26). 49. 32017 R 0079: Commission Delegated Regulation (EU) 2017/79 of 12 September 2016 establishing detailed technical requirements and test procedures for the EC type-approval of motor vehicles with respect to their 112-based eCall in-vehicles systems, of 112-based eCall in-vehicle separate technical units and components and supplementing and amending Regulation (EU) 2015/758 of the European Parliament and of the Council with regard to the exemptions and applicable standards (OJ L 12, 17.1.2017, p. 44).’
32017 D 0009: Commission Implementing Decision (EU) 2017/9 of 4 January 2017 authorising certain laboratories in Morocco and Taiwan to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets (OJ L 3, 6.1.2017, p. 32).

This act shall not apply to Iceland.’
DECISION No 65/2018 OF THE JOINT COMMITTEE ESTABLISHED UNDER THE AGREEMENT ON MUTUAL RECOGNITION BETWEEN THE EUROPEAN COMMUNITY AND THE UNITED STATES OF AMERICA

of 20 March 2019

related to the listing of Conformity Assessment Bodies under the Sectoral Annex for Telecommunication Equipment and the Sectoral Annex for Electromagnetic Compatibility [2019/558]

THE JOINT COMMITTEE,

Having regard to the Agreement on Mutual Recognition between the European Community and the United States of America and in particular Articles 7 and 14;

Whereas the Joint Committee is to take a decision to list a Conformity Assessment Body or Bodies under a Sectoral Annex,

HAS DECIDED AS FOLLOWS:

1. The Conformity Assessment Body in Attachment A is added to the list of Conformity Assessment Bodies under column ‘US access to the EC market’ in Section V of the Sectoral Annex for Telecommunication Equipment.

2. The Conformity Assessment Body in Attachment B is added to the list of Conformity Assessment Bodies under column ‘US access to the EC market’ in Section V of the Sectoral Annex for Electromagnetic Compatibility.

3. The specific scope of listing, in terms of products and conformity assessment procedures, of the Conformity Assessment Body indicated in Attachment A and Attachment B has been agreed by the Parties and will be maintained by them.
(4)

The following points are added: ‘(A) In Article 3(1)(m), the words “and of the EFTA Court, in accordance with the EEA Agreement” shall be added after the words “Court of Justice of the European Union”. (…) (C) In Article 21a(4), the following subparagraph shall be added: “Where the laws, regulations and administrative provisions notified by an EFTA State pursuant to paragraph 1 of this Article are in conformity with the conditions set out in this Chapter, the EFTA Surveillance Authority shall issue a recommendation to amend Annex VII to the EEA Agreement to update the titles adopted by the EFTA States for evidence of formal qualifications and, where appropriate, the body which issues the evidence of formal qualifications, the certificate which accompanies it and the corresponding professional title. The EEA Joint Committee shall take recommendations issued by the EFTA Surveillance Authority into account when amending Annex VII to the EEA Agreement.”’
(2)

Commission Implementing Decision (EU) 2017/888 of 22 May 2017 amending Decision 2003/467/EC as regards the official tuberculosis-free status of the region of Umbria of Italy and of the enzootic-bovine-leukosis-free status of Poland, amending Decision 2004/558/EC as regards the infectious bovine rhinotracheitis-free status of Germany, and amending Decision 2008/185/EC as regards the Aujeszky's disease-free status of certain regions of Poland and the approval of the eradication programme for Aujeszky's disease for the region of Veneto of Italy (2) is to be incorporated into the EEA Agreement.
Official Journal of the European Union

DECISION OF THE EEA JOINT COMMITTEE

No 138/2017

of 7 July 2017

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/745]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2017/306 of 6 February 2017 indicating design, construction and performance requirements and testing standards for marine equipment (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1 The following point is inserted after point 2 (Directive 2014/90/EU of the European Parliament and of the Council) of Chapter XXXII of Annex II to the EEA Agreement: ‘3. 32017 R 0306: Commission Implementing Regulation (EU) 2017/306 of 6 February 2017 indicating design, construction and performance requirements and testing standards for marine equipment (OJ L 48, 24.2.2017, p. 1).’

Article 2 The text of Implementing Regulation (EU) 2017/306 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3 This Decision shall enter into force on 8 July 2017, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).

Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 7 July 2017. For the EEA Joint Committee The President Sabine MONAUNI

(1) OJ L 48, 24.2.2017, p. 1.

(*1) No constitutional requirements indicated.
DECISION OF THE EEA JOINT COMMITTEE

No 183/2017

of 22 September 2017

amending Annex XI (Electronic communication, audiovisual services and information society) to the EEA Agreement [2019/1071]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Decision (EU) 2017/191 of 1 February 2017 amending Decision 2010/166/EU, in order to introduce new technologies and frequency bands for mobile communication services on board vessels (MCV services) in the European Union (1) is to be incorporated into the EEA Agreement.

(2) Annex XI to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1 The following is added in point 5czg (Commission Decision 2010/166/EU) of Annex XI to the EEA Agreement: ‘, as amended by: — 32017 D 0191: Commission Implementing Decision (EU) 2017/191 of 1 February 2017 (OJ L 29, 3.2.2017, p. 63).’

Article 2 The text of Implementing Decision (EU) 2017/191 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3 This Decision shall enter into force on 23 September 2017, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).

Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 22 September 2017. For the EEA Joint Committee The President Sabine MONAUNI

(1) OJ L 29, 3.2.2017, p. 63.

(*1) No constitutional requirements indicated.
(1)

Commission Regulation (EU) 2017/735 of 14 February 2017 amending, for the purpose of its adaptation to technical progress, the Annex to Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (1) is to be incorporated into the EEA Agreement.
(5)

Commission Implementing Regulation (EU) 2017/805 of 11 May 2017 renewing the approval of the active substance flazasulfuron in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) is to be incorporated into the EEA Agreement.
DECISION OF THE EEA JOINT COMMITTEE No 37/2019

of 29 March 2019

amending Annex IX (Financial Services) to the EEA Agreement [2019/1223]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Delegated Regulation (EU) 2019/397 of 19 December 2018 amending Delegated Regulation (EU) 2016/2251 supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council as regards the date until which counterparties may continue to apply their risk-management procedures for certain OTC derivative contracts not cleared by a CCP (1) is to be incorporated into the EEA Agreement.

(2) Annex IX to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1 The following indent is added in point 31bcs (Commission Delegated Regulation (EU) 2016/2251) of Annex IX to the EEA Agreement: ‘— 32019 R 0397 : Commission Delegated Regulation (EU) 2019/397 of 19 December 2018 ( : Commission Delegated Regulation (EU) 2019/397 of 19 December 2018 ( OJ L 71, 13.3.2019, p. 15 ).’

Article 2 The text of Delegated Regulation (EU) 2019/397 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3 This Decision shall enter into force on 29 March 2019 or on the day following the last notification under Article 103(1) of the EEA Agreement (*1) or on the day of the entry into force of the Decision of the EEA Joint Committee incorporating Commission Delegated Regulation (EU) 2016/2251 into the EEA Agreement, whichever is the later.

Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 29 March 2019. For the EEA Joint Committee The President Claude MAERTEN

(1) OJ L 71, 13.3.2019, p. 15

(*1) No constitutional requirements indicated.
(1)

Commission Delegated Regulation (EU) 2019/979 of 14 March 2019 supplementing Regulation (EU) 2017/1129 of the European Parliament and of the Council with regard to regulatory technical standards on key financial information in the summary of a prospectus, the publication and classification of prospectuses, advertisements for securities, supplements to a prospectus, and the notification portal, and repealing Commission Delegated Regulation (EU) No 382/2014 and Commission Delegated Regulation (EU) 2016/301 (1) is to be incorporated into the EEA Agreement.