(1)

Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

(2)

On 3 January 2022, the Sanctions Committee of the United Nations Security Council decided to remove five entries from the list of persons, groups and entities to whom the freezing of funds and economic resources should apply.

(3)

Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly,

(1)

The Protocol to the Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (‘the Barcelona Convention’) for the Prevention and Elimination of Pollution of the Mediterranean Sea by Dumping from Ships and Aircraft or Incineration at Sea (‘the Dumping Protocol’) was concluded by the Union by means of Council Decision 77/585/EEC (1) and entered into force on 15 April 1978.

(2)

Pursuant to Article 18(2), point (iii), of the Barcelona Convention, the meeting of the Contracting Parties to the Barcelona Convention and its Protocols is to adopt amendments to the annexes to the Protocols to the Convention.

(3)

During their 22nd meeting from 7 to 10 December 2021, the Contracting Parties to the Barcelona Convention and its Protocols are expected to adopt a decision (‘the Decision of the Contracting Parties’) amending the Annex to the Dumping Protocol on the factors to be considered in establishing criteria governing the issue of permits for the dumping of matter at sea taking into account Article 6 of the Dumping Protocol.

(4)

The Decision of the Contracting Parties relates to the protection of the environment, which is a shared competence between the Union and its Member States under Article 4(2), point (e), of the Treaty. The Decision of the Contracting Parties does not fall within an area which is largely covered by Union rules concerning such protection. The Union does not intend to make use of the possibility of exercising its external competence with regard to areas covered by the Decision of the Contracting Parties in relation to which its competence has not yet been exercised internally.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf at the meeting of the Contracting Parties to the Barcelona Convention and its Protocols, as the Decision of the Contracting Parties concerns the adoption of amendments to the Annex to the Dumping Protocol that will be binding on the Union.

(6)

Since the envisaged amendments to the Annex to the Dumping Protocol will update requirements regarding the protection of the Mediterranean Sea, affect the Union’s international commitments and ambitions and improve the protection of the environment, the Union should support the adoption of the Decision of the Contracting Parties,

(1)

The amended Protocol to the Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (‘the Barcelona Convention’) for the Protection of the Mediterranean Sea against Pollution from Land-Based Sources and Activities (‘the LBS Protocol’) was concluded by the Union by means of Council Decision 1999/801/EC (1) and entered into force on 11 May 2008.

(2)

Pursuant to Article 18(2), point (iii), of the Barcelona Convention, the meeting of the Contracting Parties to the Barcelona Convention and its Protocols is to adopt amendments to the annexes to the Protocols to the Convention.

(3)

During their 22nd meeting from 7 to 10 December 2021, the Contracting Parties to the Barcelona Convention and its Protocols are expected to adopt a decision (‘the Decision of the Contracting Parties’) amending Annexes I, II and IV to the LBS Protocol to take into account regulatory, scientific and technical developments related to land-based sources and activities that have been achieved at both global and regional levels.

(4)

The Decision of the Contracting Parties relates to the protection of the environment, which is a shared competence between the Union and its Member States under Article 4(2), point (e), of the Treaty. The Decision of the Contracting Parties does not fall within an area which is largely covered by Union rules concerning such protection. The Union does not intend to make use of the possibility of exercising its external competence with regard to areas covered by the Decision of the Contracting Parties in relation to which its competence has not yet been exercised internally.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf at the meeting of the Contracting Parties to the Barcelona Convention and its Protocols, as the Decision of the Contracting Parties concerns the adoption of amendments to Annexes I, II and IV to the LBS Protocol that will be binding on the Union.

(6)

Since the envisaged amendments to Annexes I, II and IV to the LBS Protocol will update requirements regarding the protection of the Mediterranean Sea, affect the Union’s international commitments and ambitions and improve the protection of the environment, the Union should support the adoption of the Decision of the Contracting Parties,

(1)

The Protocol to the Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (‘the Barcelona Convention’) for the Protection of the Mediterranean Sea against Pollution Resulting from Exploration and Exploitation of the Continental Shelf and the Seabed and its Subsoil (‘the Offshore Protocol’) was concluded by the Union by means of Council Decision 2013/5/EU (1) and entered into force on 29 March 2013.

(2)

Pursuant to Article 18(2), point (iii), of the Barcelona Convention, the meeting of the Contracting Parties to the Barcelona Convention and its Protocols is to adopt amendments to the annexes to the Protocols to the Convention.

(3)

During their 22nd meeting from 7 to 10 December 2021, the Contracting Parties to the Barcelona Convention and its Protocols are expected to adopt a decision (‘the Decision of the Contracting Parties’) amending Annexes I, II, III and IV and Annex VII, section A, to the Offshore Protocol.

(4)

The Decision of the Contracting Parties relates to the protection of the environment, which is a shared competence between the Union and its Member States under Article 4(2), point (e), of the Treaty. The Decision of the Contracting Parties does not fall within an area which is largely covered by Union rules concerning such protection. The Union does not intend to make use of the possibility of exercising its external competence with regard to areas covered by the Decision of the Contracting Parties in relation to which its competence has not yet been exercised internally.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf at the meeting of the Contracting Parties to the Barcelona Convention and its Protocols, as the Decision of the Contracting Parties concerns the adoption of amendments to Annexes I, II, III and IV and Annex VII, section A, to the Offshore Protocol that will be binding on the Union.

(6)

Since the envisaged amendments to Annexes I, II, III and IV and Annex VII, section A, to the Offshore Protocol will update requirements regarding the protection of the Mediterranean Sea, affect the Union’s international commitments and ambitions and improve the protection of the environment, the Union should support the adoption of the Decision of the Contracting Parties,

(1)

The amended Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (‘the Barcelona Convention’) was concluded by the Union by means of Council Decision 1999/802/EC (1) and entered into force on 9 July 2004.

(2)

Pursuant to Article 18(2), point (vi), of the Barcelona Convention, the meeting of the Contracting Parties to the Barcelona Convention and its Protocols is to consider and undertake any action that may be required for the achievement of the purposes of the Barcelona Convention and the Protocols. Pursuant to Rule 43 of the Rules of Procedure for meetings of the Contracting Parties, unless otherwise provided by the Barcelona Convention, the Protocols or the financial terms of reference, substantive decisions are to be made by a two-thirds majority of the Contracting Parties present and voting.

(3)

During their 22nd meeting from 7 to 10 December 2021, the Contracting Parties to the Barcelona Convention and its Protocols are expected to adopt a decision (‘the Decision of the Contracting Parties’) to submit to the 78th session of the Marine Environment Protection Committee (‘MEPC 78’) of the International Maritime Organization in 2022 a proposal to designate the Mediterranean Sea, as a whole, as an emission control area for sulphur oxides (Med SOx ECA) and to specify the date of entry into force.

(4)

The Decision of the Contracting Parties relates to the protection of the environment, which is a shared competence between the Union and its Member States under Article 4(2), point (e), of the Treaty. The Decision of the Contracting Parties does not fall within an area which is largely covered by Union rules concerning such protection. The Union does not intend to make use of the possibility of exercising its external competence with regard to areas covered by the Decision of the Contracting Parties in relation to which its competence has not yet been exercised internally.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf at the meeting of the Contracting Parties to the Barcelona Convention and its Protocols, as the Decision of the Contracting Parties concerns the submission of a proposal to MEPC 78, on behalf of an organisation to which the Union is a Party, to designate the Mediterranean Sea, as a whole, as an emission control area for sulphur oxides (Med SOx ECA), and therefore constitutes an act having legal effects.

(6)

Since the purpose of the Decision of the Contracting Parties is to lead to the update of the requirements regarding the protection of the Mediterranean Sea, in line with the Union’s ambition to reduce pollution in the marine environment and protect human health, the Union should support the adoption of the Decision of the Contracting Parties,

(1)

The amended Protocol to the Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (‘the Barcelona Convention’) for the Protection of the Mediterranean Sea against Pollution from Land-Based Sources and Activities (‘the LBS Protocol’) was concluded by the Union by means of Council Decision 1999/801/EC (1) and entered into force on 11 May 2008.

(2)

Pursuant to Article 15(1) of the LBS Protocol, the meeting of the Contracting Parties to the Barcelona Convention and its Protocols is to adopt regional action plans containing measures and timetables for their implementation.

(3)

During their 22nd meeting from 7 to 10 December 2021, the Contracting Parties to the Barcelona Convention and its Protocols are expected to adopt a decision (‘the Decision of the Contracting Parties’) to amend the Regional Plan on Marine Litter Management in the Mediterranean (‘the Regional Plan’) in the framework of Article 15 of the LBS Protocol. The Decision of the Contracting Parties will provide new definitions and will expand the scope of measures in four key areas (economic instruments, circular economy of plastics, land-based sources of marine litter and sea-based sources of marine litter).

(4)

The Decision of the Contracting Parties relates to the protection of the environment, which is a shared competence between the Union and its Member States under Article 4(2), point (e), of the Treaty. The Decision of the Contracting Parties does not fall within an area which is largely covered by Union rules concerning such protection. The Union does not intend to make use of the possibility of exercising its external competence with regard to areas covered by the Decision of the Contracting Parties in relation to which its competence has not yet been exercised internally.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf at the meeting of the Contracting Parties to the Barcelona Convention and its Protocols, as the Decision of the Contracting Parties concerns the adoption of amendments to the Regional Plan that will be binding on the Union pursuant to Article 15(3) of the LBS Protocol.

(6)

Since the envisaged amendments to the Regional Plan are in line with the Union’s ambition to reduce pollution and improve the protection of the environment, the Union should support the adoption of the Decision of the Contracting Parties,

(1)

The amended Protocol to the Convention for the Protection of the Marine Environment and the Coastal Region of the Mediterranean (‘the Barcelona Convention’) for the Protection of the Mediterranean Sea against Pollution from Land-Based Sources and Activities (‘the LBS Protocol’) was concluded by the Union by means of Council Decision 1999/801/EC (1) and entered into force on 11 May 2008.

(2)

Pursuant to Article 15(1) of the LBS Protocol, the meeting of the Contracting Parties to the Barcelona Convention and its Protocols is to adopt regional action plans containing measures and timetables for their implementation.

(3)

During their 22nd meeting from 7 to 10 December 2021, the Contracting Parties to the Barcelona Convention and its Protocols are expected to adopt a decision (‘the Decision of the Contracting Parties’) adopting Regional Plans on Urban Wastewater Treatment and Sewage Sludge Management (‘the Regional Plans’) in the framework of Article 15 of the LBS Protocol.

(4)

The Decision of the Contracting Parties relates to the protection of the environment, which is a shared competence between the Union and its Member States under Article 4(2), point (e), of the Treaty. The Decision of the Contracting Parties does not fall within an area which is largely covered by Union rules concerning such protection. The Union does not intend to make use of the possibility of exercising its external competence with regard to areas covered by the Decision of the Contracting Parties in relation to which its competence has not yet been exercised internally.

(5)

It is appropriate to establish the position to be taken on the Union’s behalf at the meeting of the Contracting Parties to the Barcelona Convention and its Protocols, as the Decision of the Contracting Parties concerns the adoption of the Regional Plans that will be binding on the Union pursuant to Article 15(3) of the LBS Protocol.

(6)

Since the purpose of the Regional Plans is to update requirements regarding the protection of the Mediterranean Sea, modify the Union’s international commitments and ambitions and improve the protection of the environment, the Union should support the adoption of the Decision of the Contracting Parties,

(1)

In accordance with Article 8(1) of Regulation (EU) 2017/746 of the European Parliament and of the Council (2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.

(2)

Regulation (EU) 2017/746 will replace Directive 98/79/EC of the European Parliament and of the Council (3) from 26 May 2022.

(3)

By Implementing Decision C(2021) 2406 (4), the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the revision of existing harmonised standards on in vitro diagnostic medical devices developed in support of Directive 98/79/EC and the drafting of new harmonised standards in support of Regulation (EU) 2017/746.

(4)

On the basis of the request set out in Implementing Decision C(2021) 2406, CEN and Cenelec revised the existing harmonised standards EN ISO 11737-1:2018, EN ISO 13408-6:2011, EN ISO 13485:2016, EN ISO 15223-1:2016 and EN ISO 17511:2003, in order to take into account the latest technical and scientific progress and to adapt them to the requirements of Regulation (EU) 2017/746. This resulted in the adoption of the revised harmonised standards EN ISO 13408-6:2021 on aseptic processing of health care products, EN ISO 15223-1:2021 on symbols to be used with information to be supplied by the manufacturer and EN ISO 17511:2021 on requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples and of amendment EN ISO 11737-1:2018/A1:2021 to harmonised standard EN ISO 11737-1:2018 on sterilization of health care products and amendment EN ISO 13485:2016/A11:2021 to harmonised standard EN ISO 13485:2016 on quality management systems.

(5)

The Commission together with CEN and Cenelec has assessed whether the harmonised standards revised by CEN and Cenelec comply with the request set out in Implementing Decision C(2021) 2406.

(6)

The harmonised standards EN ISO 13408-6:2021, EN ISO 15223-1:2021 and EN ISO 17511:2021 and the amendments EN ISO 11737-1:2018/A1:2021 and EN ISO 13485:2016/A11:2021 satisfy the requirements which they aim to cover and which are set out in Regulation (EU) 2017/746. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

(7)

The Annex to Commission Implementing Decision (EU) 2021/1195 (5) lists the references of harmonised standards drafted in support of Regulation (EU) 2017/746. In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/746 are listed in one act, the references of standards EN ISO 13408-6:2021, EN ISO 15223-1:2021 and EN ISO 17511:2021 and the amendments EN ISO 11737-1:2018/A1:2021 and EN ISO 13485:2016/A11:2021 should be included in that Implementing Decision.

(8)

Implementing Decision (EU) 2021/1195 should therefore be amended accordingly.

(9)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication,