(1)

The COVID-19 pandemic has led to a sharp drop in rail traffic caused by a significant fall in demand. This has had a serious impact on railway undertakings.

(2)

Those circumstances are beyond the control of railway undertakings, which have continuously faced considerable liquidity problems, major losses and in some cases are risking insolvency.

(3)

In order to counteract the negative economic effects of the COVID-19 pandemic and to support railway undertakings, Regulation (EU) 2020/1429 of the European Parliament and of the Council (3) enabled Member States to authorise infrastructure managers to reduce, waive or defer charges for accessing rail infrastructure. That possibility was granted for a reference period from 1 March 2020 until 31 December 2020 and was further extended by Commission Delegated Regulation (EU) 2021/1061 (4) until 31 December 2021.

(4)

The continuation of the COVID-19 pandemic and the emergence of very contagious and unpredictable variants, such as the COVID-19 Omicron variant, mean that new restrictive measures might be necessary.

(5)

The negative impact of the COVID-19 pandemic on rail traffic is persisting and it is possible that railway undertakings will continue to be affected. In an effort to respond to the urgent needs of the sector, the reference period set by Regulation (EU) 2020/1429 should be further extended until 30 June 2022.

(6)

The unforeseeable evolution of the COVID-19 pandemic, the sudden emergence of new variants and the need to assess their impact on the railway sector requires a swift and flexible regulatory response. In order to avoid a gap in the response to the current situation, it is essential to ensure that the rules continue to apply after 31 December 2021. Given the nature of the measures provided for by Regulation (EU) 2020/1429, the retroactive application of the extension of the reference period does not result in a violation of the legitimate expectations of the persons concerned.

(7)

The Commission should continuously analyse the economic impact of the COVID-19 pandemic on the rail sector and the Union should be in a position to prolong without undue delay the period of application of the measures provided for by Regulation (EU) 2020/1429 if the adverse conditions persist.

(8)

In order to extend, if necessary and justified, the validity of the rules provided for in Regulation (EU) 2020/1429, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of prolonging the reference period during which the measures provided for by Regulation (EU) 2020/1429 apply. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (5). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(9)

Since the objective of this Regulation, namely to extend the application of the temporary rules on the levying of charges for the use of railway infrastructure laid down in response to the urgent situation created by the COVID-19 pandemic, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective.

(10)

Regulation (EU) 2020/1429 should therefore be amended accordingly.

(11)

In view of urgency entailed by the exceptional circumstances caused by the COVID-19 pandemic justifying the proposed measures, and more particularly in order to adopt the necessary measures quickly so as to address the severe and immediate problems faced by the sector, it is considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.

(12)

In order to ensure continuity and to allow for the prompt application of the measures provided for in this Regulation, it should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union, and should apply, with retroactive effect, from 1 January 2022,

(1)

Relations between the European Union (the ‘Union’) and Ukraine continue to develop within the framework of the European Neighbourhood Policy (ENP) and the Eastern Partnership. An association agreement between the Union and Ukraine (2) (the ‘Association Agreement’), including a Deep and Comprehensive Free Trade Area (DCFTA), entered into force on 1 September 2017.

(2)

In spring 2014, Ukraine embarked on an ambitious reform programme with the aim of stabilising its economy and improving the livelihoods of its citizens. The fight against corruption as well as constitutional, electoral and judicial reforms are among the top priorities on the agenda. The implementation of those reforms was supported by five consecutive macro-financial assistance programmes, under which Ukraine has received assistance in the form of loans for a total of EUR 5 billion. The latest macro-financial assistance, which was made available in the context of the COVID-19 pandemic pursuant to Decision (EU) 2020/701 of the European Parliament and of the Council (3), provided EUR 1,2 billion in loans to Ukraine and was completed in September 2021.

(3)

The economy of Ukraine has been affected by the recession in 2020, which was caused by the COVID-19 pandemic and by prolonged security threats at its border with Russia. The continuous build-up of uncertainty has resulted in a recent loss of confidence, negatively affecting the economic outlook, and, since mid-January 2022, in the loss of access to international capital markets. The deteriorating financing conditions have contributed to a sizable and increasing residual external financing gap and weigh heavily on investment, thereby weakening Ukraine’s resilience to future economic and political shocks.

(4)

The Ukrainian government has demonstrated a strong commitment to implement further reforms focusing, at the current critical juncture, in the short term on key policy areas such as economic resilience and stability, governance and rule of law, and energy.

(5)

A renewed commitment to carry out such reforms and a strong political will has led the Ukranian authorities to accelerate the implementation of reforms since the summer of 2021. This has also enabled Ukraine to successfully complete the macro-financial assistance operation in the context of the COVID-19 pandemic, as all reform actions agreed with the Union in the Memorandum of Understanding were fulfilled.

(6)

To allow for more policy flexibility in the context of the crisis related to the COVID-19 pandemic, the International Monetary Fund (IMF) approved an 18-month Stand-by Arrangement for Ukraine with access equivalent to USD 5 billion in June 2020. That arrangement focuses on four priorities: (i) mitigating the economic impact of the crisis, including by supporting households and businesses; (ii) ensuring continued central bank independence and a flexible exchange rate; (iii) safeguarding financial stability while recovering the costs from bank resolutions; and (iv) moving forward with key governance and anti-corruption measures to preserve and deepen recent gains. Due to an uneven implementation record, the first programme review, which also agreed on an extension of the programme until the end of June 2022, was not concluded until November 2021. This brought total disbursements under the current IMF programme to the equivalent of USD 2,8 billion thus far. Two more reviews are planned to take place by the end of the second quarter of 2022.

(7)

In view of high budget financing risks and in the context of a slow recovery from the crisis related to the COVID-19 pandemic and quickly accelerating inflation, Ukraine requested a new long-term macro-financial assistance programme for up to EUR 2,5 billion from the Union on 16 November 2021. Such emergency macro-financial assistance responds, in particular, to the sharp and unexpected increase in the external financing needs of Ukraine, triggered by the de facto loss of access to financial markets, and to the underlying immediate challenges.

(8)

Given that Ukraine is a country covered by the ENP, it should be considered to be eligible to receive macro-financial assistance from the Union.

(9)

The Union’s macro-financial assistance should be an exceptional financial instrument of untied and undesignated balance-of-payments support, which aims to address the beneficiary’s immediate external financing needs and should underpin the implementation of a policy programme containing strong immediate adjustment and structural reform measures designed to improve the beneficiary’s balance-of-payments position in the short term and economic resilience in the medium term.

(10)

Given that the loss of market access and the capital outflow have created a significant residual external financing gap in Ukraine’s balance of payments over and above the resources provided by the IMF and other multilateral institutions, the swift provision by the Union of emergency macro-financial assistance to Ukraine is, under the current exceptional circumstances, considered to be an appropriate short-term response to the sizeable risks to the country. The Union’s macro-financial assistance would support Ukraine’s economic stabilisation and aim to strengthen the immediate resilience of the country, as well as and where feasible at present, strengthen the structural reform agenda of Ukraine, supplementing resources made available under the IMF’s financial arrangement.

(11)

The Union’s macro-financial assistance should aim to support the restoration of a sustainable external financing situation for Ukraine, thereby supporting its economic and social development.

(12)

The Union’s macro-financial assistance is expected to go hand-in-hand with the implementation of budget support operations under the Neighbourhood, Development and International Cooperation Instrument – Global Europe, established by Regulation (EU) 2021/947 of the European Parliament and of the Council (4).

(13)

The determination of the amount of the Union’s macro-financial assistance is based on a quantitative assessment of Ukraine’s residual external financing needs, and takes into account its capacity to finance itself with its own resources, in particular the international reserves at its disposal. The Union’s macro-financial assistance should complement the programmes and resources provided by the IMF and the World Bank. The determination of the amount of the assistance also takes into account expected financial contributions from multilateral donors and the need to ensure fair burden sharing between the Union and other donors, as well as the pre-existing deployment of the Union’s other external financing instruments in Ukraine and the added value of the overall Union involvement.

(14)

The Commission should ensure that the Union’s macro-financial assistance is legally and substantially in accordance with the key principles and objectives of, and the measures taken within the different areas of external action and other relevant Union policies.

(15)

The Union’s macro-financial assistance should support the Union’s external policy towards Ukraine. The Commission and the European External Action Service should work closely together throughout the macro-financial assistance operation in order to coordinate, and ensure the consistency of, Union external policy.

(16)

The Union’s macro-financial assistance should support Ukraine’s commitment to values shared with the Union, including democracy, the rule of law, good governance, respect for human rights, sustainable development and poverty reduction, as well as its commitment to the principles of open, rule-based and fair trade.

(17)

A precondition for granting the Union’s macro-financial assistance should be that Ukraine respects effective democratic mechanisms, including a multi-party parliamentary system, and the rule of law, and guarantees respect for human rights. In addition, the specific objectives of the Union’s macro-financial assistance should strengthen the efficiency, transparency and accountability of the public finance management systems and should promote structural reforms aimed at supporting sustainable and inclusive growth, decent employment creation and fiscal consolidation. The Commission and the European External Action Service should regularly monitor both the fulfilment of the precondition and the achievement of those objectives.

(18)

In order to ensure that the Union’s financial interests linked to the Union’s macro-financial assistance are protected efficiently, Ukraine should take appropriate measures relating to the prevention of, and fight against, fraud, corruption and any other irregularities linked to that assistance. In addition, provision should be made for the Commission to carry out checks, for the Court of Auditors to carry out audits and for the European Public Prosecutor’s Office to exercise its competences.

(19)

Release of the Union’s macro-financial assistance is without prejudice to the powers of the European Parliament and the Council as budgetary authority.

(20)

The amounts of provisioning required for the Union’s macro-financial assistance should be consistent with the budgetary appropriations provided for in the multiannual financial framework.

(21)

The Union’s macro-financial assistance should be managed by the Commission. In order to ensure that the European Parliament and the Council are able to follow the implementation of this Decision, the Commission should regularly inform them of developments relating to that assistance and provide them with the relevant documents.

(22)

In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (5).

(23)

The Union’s macro-financial assistance should be subject to economic policy conditions, to be set out in a memorandum of understanding (MOU). In order to ensure uniform conditions of implementation and for reasons of efficiency, the Commission should be empowered to negotiate such conditions with the Ukrainian authorities under the supervision of the committee of representatives of the Member States in accordance with Regulation (EU) No 182/2011. Under that Regulation, the advisory procedure should, as a general rule, apply in all cases other than as provided for in that Regulation. Considering the potentially significant impact of assistance of more than EUR 90 million, it is appropriate that the examination procedure as specified in Regulation (EU) No 182/2011 be used for operations above that threshold. Considering the amount of the Union’s macro-financial assistance to Ukraine, the examination procedure should apply to the adoption of the MOU, and to any reduction, suspension or cancellation of the assistance.

(24)

Since the objective of this Decision, namely to provide emergency macro-financial assistance to Ukraine with a view to supporting, in particular, its economic resilience and stability, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary to achieve that objective.

(25)

In view of the urgency entailed by the exceptional circumstances caused by the COVID-19 pandemic and the associated economic consequences, it is considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the TEU, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.

(26)

In order to allow for the prompt application of measures laid down in this Decision, this Decision should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union,

(1)

On 22 June 2018, the Council authorised the Commission to open negotiations with the North Pacific Fisheries Commission for the Union to accede to the Convention on the Conservation and Management of High Seas Fisheries Resources in the North Pacific Ocean (the ‘Convention’).

(2)

The Union is competent to adopt measures for the conservation of marine biological resources under the common fisheries policy and to enter into agreements with third countries and international organisations.

(3)

Pursuant to Council Decision 98/392/EC (2), the Union is a contracting party to the United Nations Convention on the Law of the Sea (‘UNCLOS’) of 10 December 1982, which requires all contracting parties to UNCLOS to cooperate in conserving and managing the biological resources of the sea.

(4)

Pursuant to Council Decision 98/414/EC (3), the Union is a contracting party to the Agreement on the implementation of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982, relating to the conservation and management of straddling fish stocks and highly migratory fish stocks.

(5)

At its sixth annual session from 23 to 25 February 2021, the North Pacific Fisheries Commission invited the Union to accede to the Convention.

(6)

Accession to the Convention should promote consistency in the Union’s conservation approach across the world’s oceans and reinforce its commitment to the long-term conservation and sustainable use of fisheries resources globally. In accordance with the joint communication of the High Representative of the Union for Foreign Affairs and Security Policy and the Commission of 10 November 2016 on ‘International ocean governance: an agenda for the future of our oceans’ and the Council conclusions of 3 April 2017 on that joint communication, promoting measures to support and enhance the effectiveness of regional fisheries management organisations and, where relevant, improve their governance is a central feature of the Union’s action in those organisations.

(7)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (4), and delivered formal comments on 27 August 2021. Personal data processed by Member States or by the Commission in the framework of the Convention is to be treated in accordance with the applicable provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council (5) and Regulation (EU) 2018/1725.

(8)

The Union should therefore accede to the Convention,

(1)

Pursuant to Article 22(a) of Commission Delegated Regulation (EU) 2016/161 (2), a wholesaler is to decommission the unique identifier of medicinal products which he intends to distribute outside of the Union.

(2)

On 1 February 2020, the United Kingdom withdrew from the European Union and from the European Atomic Energy Community. Pursuant to Articles 126 and 127 of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (the ‘Withdrawal Agreement’), Union law was applicable to and in the United Kingdom during a transition period that ended on 31 December 2020 (‘the ‘transition period’).

(3)

In accordance with Article 185 of the Withdrawal Agreement and Article 5(4) of the Protocol on Ireland/Northern Ireland, Union legislation on medicinal products continued to apply in Northern Ireland after the end of the transition period.

(4)

The withdrawal of the United Kingdom from the Union would, in the absence of a derogation from the applicable rules, have had the effect that unique identifiers must be decommissioned for medicinal products intended to be distributed in the United Kingdom except Northern Ireland.

(5)

On 13 January 2021, Delegated Regulation (EU) 2016/161 was amended by Commission Delegated Regulation (EU) 2021/457 (3) to provide a derogation from the requirement to decommission unique identifiers of products exported to the United Kingdom until 31 December 2021. This derogation was intended to ensure the supply of medicinal products to small markets historically dependent on the United Kingdom, i.e. Northern Ireland, Cyprus, Ireland and Malta. In those small markets historically dependent on the United Kingdom, many medicinal products were and continue to be purchased from the United Kingdom by wholesalers not holding manufacturing and importation authorisations and therefore unable to meet the importation requirements laid down in Directive 2001/83/EC and Delegated Regulation (EU) 2016/161.

(6)

In order to ensure that medicinal products continue to be marketed with a unique identifier in Northern Ireland, Cyprus, Ireland and Malta, it is necessary to further extend the temporary derogation from the requirement to decommission unique identifiers of products exported to the United Kingdom. An additional three-year period is needed to allow industry sufficient time to adapt the supply chains of medicines destined for Northern Ireland, Cyprus, Ireland and Malta. The derogation should, however, be limited to medicinal products solely intended for the United Kingdom market or for the United Kingdom market jointly with Cyprus, Ireland or Malta. It should not apply to medicinal products intended for markets other than the United Kingdom or packaged in EU-wide or global labelling. This derogation should not affect the application of Union law to and in the United Kingdom in respect of Northern Ireland in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement in conjunction with Annex 2 to that Protocol.

(7)

In order to accommodate the specific characteristics of national supply chains, Article 23 of Delegated Regulation (EU) 2016/161 allows Member States to require wholesalers to verify and decommission unique identifiers on behalf of a list of persons or institutions referred to in that Article. In many cases, this would mean that wholesalers established in parts of the United Kingdom other than Northern Ireland should verify and decommission the unique identifiers of medicines supplied to those persons or institutions in Northern Ireland. Since those wholesalers are not connected to the Union repository system, it is necessary to grant an exceptional derogation from the requirement to decommission the unique identifiers of a medicinal product in order to allow these wholesalers time to move the verification and decommissioning operations to Northern Ireland.

(8)

The purpose of Delegated Regulation (EU) 2016/161 is to set out the specifications of the unique identifier, the safety features and the repositories system with a view to establishing a reliable authentication system for medicinal products in the Union. This mutual trust is undermined if repositories outside the Union can upload and access sensitive content in the system, in particular in light of the limited means to supervise such repositories.

(9)

In order to ensure that medicinal products re-imported into the Union are not placed on the market elsewhere than Northern Ireland, Cyprus, Ireland and Malta, it is necessary to ensure that the repositories system provide an alert when the medicinal product is verified elsewhere in the Union. Wholesalers in Northern Ireland, Cyprus, Ireland and Malta should also perform checks of shipments of medicinal products intended for the United Kingdom market received from manufacturers, marketing authorisation holders and wholesalers designated by the marketing authorisation holder to ensure the products they receive comply with the rules on safety features.

(10)

Delegated Regulation (EU) 2016/161 should therefore be amended accordingly.

(11)

Having regard to the imminent end of the current derogation, this Regulation should enter into force as a matter of urgency. As the current derogation ends on 31 December 2021, this Regulation should apply from 1 January 2022,

(1)

The Commission has examined the application for the approval of amendments to the specification for the Protected Designation of Origin ‘Tarragona’, forwarded by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.

(2)

The Commission has published the application for the approval of the amendments to the specification in the Official Journal of the European Union (2), as required by Article 97(3) of Regulation (EU) No 1308/2013.

(3)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(4)

The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

(1)

In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Dehesa Peñalba’ forwarded by Spain and has published it in the Official Journal of the European Union (2).

(2)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(3)

In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Dehesa Peñalba’ should be protected and entered in the register referred to in Article 104 of that Regulation.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Lithuania’s application to register the name ‘Nijolės Šakočienės šakotis’ was published in the Official Journal of the European Union (2).

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Nijolės Šakočienės šakotis’ should therefore be entered in the register,

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Trote del Trentino’, registered under Commission Implementing Regulation (EU) No 910/2013 (2).

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendment to the specification should be approved,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Mandarin essential oil was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of expressed mandarin essential oil for all animal species.

(4)

The applicant requested expressed mandarin essential oil to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore, the use of expressed mandarin essential oil in water for drinking should not be allowed.

(5)

The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(6)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 (3) that, under the proposed conditions of use, expressed mandarin essential oil does not have adverse effects on animal health, consumer health or the environment. However, no conclusions could be drawn for companion animals and ornamental fish not normally exposed to citrus by-products. The Authority also concluded that expressed mandarin essential oil should be considered as a skin sensitiser and as an irritant to skin, eyes and the respiratory tract. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(7)

The Authority also concluded, that expressed mandarin essential oil is recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(8)

The assessment of expressed mandarin essential oil shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the substance should be authorised as specified in the Annex to this Regulation.

(9)

The fact that expressed mandarin essential oil is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed which is administered via water.

(10)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Council Decision (EU) 2020/430 (1) introduced a one-month derogation from the first subparagraph of Article 12(1) of the Council’s Rules of Procedure (2) as regards decisions to use the ordinary written procedure, where those decisions are taken by the Committee of the Permanent Representatives of the Governments of the Member States (Coreper). That derogation was foreseen to last until 23 April 2020.

(2)

Decision (EU) 2020/430 provides that, if justified by continued exceptional circumstances, the Council may renew that Decision. On 21 April 2020, the Council, by means of Decision (EU) 2020/556 (3), extended the derogation provided for in Article 1 of Decision (EU) 2020/430 for a further period of one month from 23 April 2020. That extension of the derogation was foreseen to last until 23 May 2020. On 20 May 2020, the Council, by means of Decision (EU) 2020/702 (4), extended the derogation provided for in Article 1 of Decision (EU) 2020/430 until 10 July 2020. On 3 July 2020, the Council, by means of Decision (EU) 2020/970 (5), extended that derogation until 10 September 2020.

On 4 September 2020, the Council, by means of Decision (EU) 2020/1253 (6), extended that derogation until 10 November 2020. On 6 November 2020, the Council, by means of Decision (EU) 2020/1659 (7), extended that derogation until 15 January 2021. On 12 January 2021, the Council, by means of Decision (EU) 2021/26 (8), extended that derogation until 19 March 2021. On 12 March 2021, the Council, by means of Decision (EU) 2021/454 (9), extended that derogation until 21 May 2021. On 20 May 2021, the Council, by means of Decision (EU) 2021/825 (10), extended that derogation until 16 July 2021.

On 12 July 2021, the Council, by means of Decision (EU) 2021/1142 (11), extended that derogation until 30 September 2021. On 24 September 2021, the Council, by means of Decision (EU) 2021/1725 (12), extended that derogation until 30 November 2021. On 25 November 2021, the Council, by means of Decision (EU) 2021/2098 (13), extended that derogation until 28 February 2022.

(3)

Given that the exceptional circumstances caused by the COVID-19 pandemic continue, with a number of extraordinary preventive and containment measures taken by Member States still in place, it is necessary to extend the derogation provided for in Article 1 of Decision (EU) 2020/430, as extended by Decisions (EU) 2020/556, (EU) 2020/702, (EU) 2020/970, (EU) 2020/1253, (EU) 2020/1659, (EU) 2021/26, (EU) 2021/454, (EU) 2021/825, (EU) 2021/1142, (EU) 2021/1725 and (EU) 2021/2098, for a further limited period until 30 June 2022,

(1)

The Convention on International Civil Aviation (the Chicago Convention), which regulates international air transport, entered into force on 4 April 1947. It established the International Civil Aviation Organization (ICAO).

(2)

The Member States of the Union are Contracting States to the Chicago Convention and members of the ICAO, while the Union has observer status in certain ICAO bodies. There are currently seven Member States represented in the Council of the ICAO (‘ICAO Council’).

(3)

Pursuant to Article 54 of the Chicago Convention, the ICAO Council is to adopt international standards and recommended practices (‘SARPs’) and designate them as Annexes to the Chicago Convention.

(4)

During its 225th session, the ICAO Council is to adopt Amendment 178 to Annex 1, Amendment 47 to Part I of Annex 6, Amendment 40 to Part II of Annex 6, Amendment 24 to Part III of Annex 6, Amendment 7 to Annex 7, Amendment 109 to Annex 8, Amendment 29 to Annex 9, Amendment 91 to Volume IV of Annex 10, Amendment 17 to Volume I of Annex 14 and Amendment 18 to Annex 17 to the Chicago Convention, as set out in State Letters AN 12/1.1.25-20/112, AN 11/1.1.34-20/75, AN 3/45-20/85, AN 3/1.2-20/76, AN 7/1.3.105-20/42, SP 55/4-20/94, AS 8/2.1-21/48 Confidential, and EC 6/3 – 21/67.

(5)

The main purpose of Amendment 178 to Annex 1 to the Chicago Convention is to enable the implementation of an electronic personnel licensing system with a view to improving efficiency.

(6)

The main purpose of Amendments 47, 40 and 24 to Parts I, II and III, respectively, of Annex 6 to the Chicago Convention is to strengthen the legal framework for the continued serviceability of flight recorders, to clarify the provisions relating to extended diversion time operations (EDTO) and infant life jackets, to mandate ground proximity warning systems (GPWS) on certain aeroplanes, to add a new standard to equip aeroplanes under certain conditions with runway overrun awareness and alerting systems (ROAAS), to provide operational credit in the context of performance-based aerodrome operating minima (PBAOM), to ensure that adequate rescue and firefighting (RFF) facilities and services are available at the intended aerodrome of operation, to update the provisions relating to offshore alternates for long-range helicopter operations and to add provisions related to the transport of dangerous goods by helicopter and update related training provisions.

(7)

The main purpose of Amendment 7 to Annex 7 to the Chicago Convention is to facilitate the transfer of an aircraft from one State to another by adapting the template for the certificate of registration and introducing a template for the certificate of deregistration.

(8)

The main purpose of Amendment 109 to Annex 8 to the Chicago Convention is to improve clarity and ensure that States approving any modification and repair have a clear understanding of their continuing airworthiness responsibility and to clarify the design capabilities of cargo compartment fire suppression in large aeroplanes, helicopters and small aeroplanes.

(9)

The main purpose of Amendment 29 to Annex 9 to the Chicago Convention is to enhance the preparedness of States for future pandemics by learning from the lessons of the COVID-19 pandemic and setting out adequate mitigation measures for future pandemics. Amendment 29 also addresses the combating of human trafficking through SARPs. Furthermore, it contains minor but useful amendments to the provisions of Annex 9 to the Chicago Convention concerning repatriation flights and the air transport of passengers with disabilities, and an amendment to the notes in the passenger name record (PNR) data section concerning the term ‘push’.

(10)

The main purpose of Amendment 91 to Volume IV of Annex 10 to the Chicago Convention is to introduce Airborne Collision Avoidance System (ACAS) X and to reduce the occurrence of false ACAS alerts.

(11)

The main purpose of Amendment 17 to Volume I of Annex 14 to the Chicago Convention is to exclude general aviation from the rescue and firefighting (RFF) provisions.

(12)

The main purpose of Amendment 18 to Annex 17 to the Chicago Convention is to introduce new SARPs and amend existing SARPs related to security culture, aircraft operator security programmes, methods of detecting explosives in hold baggage, and national civil aviation security quality-control programmes.

(13)

It is appropriate to establish the position to be taken on the Union’s behalf within the ICAO Council, as Amendment 178 to Annex 1, Amendment 47 to Part I of Annex 6, Amendment 40 to Part II of Annex 6, Amendment 24 to Part III of Annex 6, Amendment 7 to Annex 7, Amendment 109 to Annex 8, Amendment 29 to Annex 9, Amendment 91 to Volume IV of Annex 10, Amendment 17 to Volume I of Annex 14 and Amendment 18 to Annex 17 to the Chicago Convention are capable of decisively influencing the content of Union law, namely Commission Regulations (EU) No 1178/2011 (1), (EU) No 1332/2011 (2), (EU) No 965/2012 (3), (EU) No 139/2014 (4) and (EU) 2015/640 (5), Commission Implementing Regulation (EU) 2015/1998 (6) and Regulation of the European Parliament and of the Council (EU) 2018/1139 (7).

(14)

The Union’s position in the 225th session of the ICAO Council or any subsequent session with regard to the adoption of Amendment 178 to Annex 1, Amendment 47 to Part I of Annex 6, Amendment 40 to Part II of Annex 6, Amendment 24 to Part III of Annex 6, Amendment 7 to Annex 7, Amendment 109 to Annex 8, Amendment 29 to Annex 9, Amendment 91 to Volume IV of Annex 10, Amendment 17 to Volume I of Annex 14 and Amendment 18 to Annex 17 to the Chicago Convention should be to support those Amendments in their entirety. That position should be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly on behalf of the Union.

(15)

The Union’s position after the adoption by the ICAO Council of Amendment 178 to Annex 1, Amendment 47 to Part I of Annex 6, Amendment 40 to Part II of Annex 6, Amendment 24 to Part III of Annex 6, Amendment 7 to Annex 7, Amendment 109 to Annex 8, Amendment 29 to Annex 9, Amendment 91 to Volume IV of Annex 10, Amendment 17 to Volume I of Annex 14 and Amendment 18 to Annex 17 to the Chicago Convention, to be announced by the ICAO Secretary-General by means of an ICAO State-letter procedure, should be not to register disapproval and to notify compliance, provided that those Amendments are adopted without substantial changes. It is also appropriate to lay down the procedure to be followed for the notification of differences to the ICAO in the event that Union legislation deviates from the newly adopted SARPs after the envisaged date of application of those SARPs. With respect to differences with the standards contained in Annexes 1, 6, 8 and 14 to the Chicago Convention falling within Union exclusive competence, Council Decision (EU) 2021/1092 (8) applies. That position should be expressed by all Member States of the Union,

(1)

On 8 April 2020, the company Sharda Cropchem España S.L. (‘the applicant’) submitted an application to France for the mutual recognition in sequence in accordance with Article 33 of Regulation (EU) No 528/2012, of a national authorisation of the biocidal product Sojet (‘the biocidal product’) already granted in Germany. The biocidal product is an insecticide of product-type 18 to be used by professionals for indoor application in industrial or commercial premises, households or private areas, public areas and animal housings for the control of flies. The biocidal product is dispersed in water and applied on cardboard sheets by brushing and contains as active substances imidacloprid and cis-Tricos-9-ene.

(2)

On 6 October 2020, pursuant to Article 35(2) of Regulation (EU) No 528/2012, France referred objections to the coordination group, indicating that the conditions of the authorisation set by Germany do not ensure that the biocidal product meets the requirement laid down in Article 19(1), point (b)(iii), of that Regulation. France considers that in order to ensure the safe handling of the biocidal product, wearing of personal protective equipment, consisting of protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and single-use coverall of at least type-6 EN 13034, is required. According to France, the application of technical and organisational measures in accordance with Council Directive 98/24/EC (2), as set out in the authorisation granted by Germany, as a possible replacement for wearing personal protective equipment does not ensure an adequate protection if those measures are not specified and evaluated in the assessment of the biocidal product.

(3)

Germany considers that Directive 98/24/EC establishes the order of preference of different risk mitigation measures for protection of workers and prioritises the application of technical and organisational measures over wearing personal protection equipment for the use of the biocidal product. According to Germany, pursuant to that Directive the employer is to decide which technical and organisational measures are to be applied, and as there is a broad range of such measures, it is not feasible to describe and evaluate the measures in the authorisation of the biocidal product.

(4)

As no agreement was reached by the coordination group, on 3 March 2021 Germany referred the unresolved objection to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012. It thereby provided the Commission with a detailed statement of the matter on which Member States were unable to reach agreement and the reasons for their disagreement. That statement was forwarded to the Member States concerned and the applicant.

(5)

Article 2(3), points (b) and (c), of Regulation (EU) No 528/2012 provides that that Regulation is to be without prejudice to Council Directive 89/391/EEC (3) and Directive 98/24/EC.

(6)

Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012 indicates as one of the criterion for granting an authorisation that the biocidal product has no unacceptable effects itself, or as a result of its residues, on the health of humans.

(7)

Point 9 of Annex VI to Regulation (EU) No 528/2012 states that the application of the common principles laid down in that Annex for the evaluation of dossiers for biocidal products referred to in Article 19(1), point (b), of that Regulation, when taken together with the other conditions set out in its Article 19, is to lead to the competent authorities or the Commission deciding whether or not a biocidal product can be authorised. Such authorisation may include restrictions on the use of the biocidal product or other conditions.

(8)

Point 18(d) of Annex VI to Regulation (EU) No 528/2012 states that the risk assessment conducted for the product is to determine the measures necessary to protect humans, animals and the environment, both during the proposed normal use of the biocidal product and in a realistic worst-case situation.

(9)

Point 56(2) of Annex VI to Regulation (EU) No 528/2012 indicates that in establishing compliance with the criteria set out in Article 19(1), point (b), one of the conclusions to which the evaluating body is to make, is that subject to specific conditions/restrictions the biocidal product can comply with the criteria.

(10)

Point 62 of Annex VI to Regulation (EU) No 528/2012 states that the evaluating body is, where appropriate, to conclude that the criterion under Article 19(1), point (b)(iii), of that Regulation can only be complied with by application of prevention and protection measures including the design of work processes, engineering controls, use of adequate equipment and materials, application of collective protection measures and, where exposure cannot be prevented by other means, application of individual protection measures including the wearing of personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles, in order to reduce exposure for professional operators.

(11)

However, point 62 of Annex VI to Regulation (EU) No 528/2012 does not provide that the assessment leading to the conclusion that the criterion under Article 19(1), point (b)(iii), of that Regulation can only be complied with by application of prevention and protection measures is to be done in accordance with Directive 98/24/EC. It also does not explicitly provide that that Directive would not apply. Therefore, it should not be inferred from those provisions that Directive 98/24/EC does not apply. In addition, the relevant obligations under Directive 98/24/EC are imposed on employers, not on the authorities of Member States.

(12)

Article 4 of Directive 98/24/EC provides that for the assessment of any risk to the safety and health of workers arising from the presence of chemical agents, employers are to obtain additional information needed from the supplier or from other readily available sources and that where appropriate, that information is to comprise the specific assessment concerning the risk to users established on the basis of Union legislation on chemical agents.

(13)

Article 6 of Directive 98/24/EC lays down prioritisation of the measures to be taken by the employer for the protection of workers from the risks related to chemical agents at work. Priority is to be given to replacement of the hazardous substance and when this is not possible, the risk from a hazardous chemical agent to the safety and health of workers at work needs to be reduced to a minimum by application of protection and prevention measures. If it is not possible to prevent exposure to the hazardous substance by other means, protection of the workers is to be ensured by applying individual protection measures including personal protective equipment.

(14)

Taking into account the method of application of the biocidal product and the available information from the evaluating body, no such technical or organisational measures have been identified in the application for authorisation of the biocidal product, nor during the evaluation of that application.

(15)

The Commission therefore considers that the biocidal product meets the criterion laid down in Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012, provided that the following condition regarding its use is included in the authorisation and on the label of the biocidal product: ‘The wearing of protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and single-use protective coverall of at least type-6 EN 13034 or equivalent is required for the handling of the product. This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work’.

(16)

However, if the applicant for authorisation or the authorising authority identify effective technical or organisational measures leading to an equivalent or higher level of exposure reduction, those measures should replace the wearing of personal protective equipment and should be specified in the authorisation and on the label of the biocidal product.

(17)

On 23 November 2021, the Commission provided the applicant with the opportunity to provide written comments in accordance with Article 36(2) of Regulation (EU) No 528/2012. The applicant provided comments which the Commission, subsequently, took into account.

(18)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

In its judgement in case T-359/19 (2), the General Court annulled Commission Implementing Decision (EU) 2019/583 (3) as regards the calculation for the calendar year 2017 of the average specific CO2 emissions, and the recorded CO2 savings from eco-innovations for the manufacturer Daimler AG and the Daimler AG pool.

(2)

Since the average specific CO2 emissions and the eco-innovation CO2 savings specified in Commission Implementing Decision (EU) 2021/973 (4) were determined in the same way as in Implementing Decision (EU) 2019/583, it is appropriate to adjust the values set out in that Decision.

(3)

The eco-innovation CO2 savings certified in accordance with Commission Implementing Decision (EU) 2015/158 (5), as reported by Members States and verified by Daimler AG and the Daimler AG pool, should be taken into account for the calculation of the average specific emissions of those entities in calendar year 2019.

(4)

The eco-innovation CO2 savings recorded in Implementing Decision (EU) 2021/973 should therefore be increased by 0,102 g CO2/km for Daimler AG and by 0,101 g CO2/km for the Daimler AG pool.

(5)

The average specific emissions of CO2 and the distance to target determined for Daimler AG and the Daimler AG pool in Implementing Decision (EU) 2021/973 have been recalculated taking into account the increase in the eco-innovation savings. It is therefore necessary to adapt the relevant entries.

(6)

Implementing Decision (EU) 2021/973 should therefore be mended accordingly,