(1)

Regulation (EU) No 648/2012 has been amended by Regulation (EU) 2019/2099 of the European Parliament and of the Council (2). Those amendments have introduced into Regulation (EU) No 648/2012, inter alia, an empowerment for the Commission to specify further the rules of procedure for the exercise by the European Securities and Markets Authority (‘ESMA’) of the power to impose fines or periodic penalty payments on third-country central counterparties (‘third-country CCPs’) and related third parties to whom third-country CCPs have outsourced operational functions or activities (‘related third parties’). In particular, those rules of procedures should include provisions on the rights of the defence, temporal provisions, and the collection of fines or periodic penalty payments and the limitation periods for the imposition and enforcement of penalties.

(2)

Article 41(2) of the Charter of Fundamental Rights of the European Union recognises the right of every person to be heard before any individual measure is taken which would affect him or her adversely, and the right of every person to have access to his or her file, while respecting the legitimate interests of confidentiality and of professional and business secrecy.

(3)

To ensure that the rights of defence of third-country CCPs and related third parties subject to actions by ESMA are respected and to ensure that ESMA takes all relevant facts into account when adopting enforcement decisions, ESMA should hear the third-country CCP or related third parties or any other persons concerned. Third-country CCPs and related third parties should therefore have the right to make written submissions in response to statements of findings issued by the investigation officer and ESMA, including in case of material changes in the initial statement of findings. The investigation officer and ESMA should also have the possibility to invite third-country CCPs and related third parties to provide further explanations at an oral hearing where the investigation officer or ESMA consider that some elements of the written submissions made to the investigation officer or to ESMA are not sufficiently clear or detailed, and that further explanation is needed.

(4)

It is important that transparency is ensured between the investigation officer appointed by ESMA in accordance with Article 25i of Regulation (EU) No 648/2012 and ESMA itself. Such transparency requires that the investigation officer’s file, in addition to the statement of findings, contains any submissions made by the third-country CCPs or related third parties, the statement of findings on the basis on which those third-country CCPs or related third parties provided their submissions, and the minutes of any oral hearing.

(5)

According to the second subparagraph of Article 25l(1) of Regulation (EU) No 648/2012, ESMA has the possibility to adopt, where urgent action is needed, interim decisions imposing fines or periodic penalty payments without first hearing the persons subject to an investigation or proceedings. To ensure the effectiveness of ESMA’s power to adopt interim decisions, the third-country CCPs and related third parties subject to an investigation should not have the right to access the file or to be heard before the investigation officer has submitted the file with his or her findings to ESMA or before ESMA has adopted its interim decision. However, to respect the rights of defence, the third-country CCPs and related third parties should have the right to access the file as soon as the investigation officer has submitted the file with his or her statement of findings to ESMA, and the right to be heard as soon as possible after ESMA has adopted its interim decision.

(6)

For reasons of consistency, limitation periods for the imposition and enforcement of fines or periodic penalty payments should take into account existing Union legislation applicable to the imposition and enforcement of penalties on supervised entities, ESMA’s experience in applying such legislation in relation to trade repositories under Regulation (EU) No 648/2012, the fact that third-country CCPs are located outside the Union and the need for ESMA to coordinate with authorities in such third-country jurisdictions in relation to enforcement actions. Limitation periods should be calculated in accordance with existing Union legislation for acts of the Council and the Commission, and in particular with Regulation (EEC, Euratom) No 1182/71 of the Council (3).

(7)

According to Article 25m(5) of Regulation (EU) No 648/2012, the amounts corresponding to the fines and periodic penalty payments collected by ESMA are to be allocated to the general budget of the Union. Fines and periodic penalty payments collected by ESMA should be lodged to interest bearing accounts until they become final. For each decision imposing fines or periodic penalty payments, the amounts collected by ESMA should be lodged to a separate account or subaccount to ensure traceability until that decision becomes final.

(8)

In the interest of the immediate exercise by ESMA of effective supervisory and enforcement powers, this Regulation should enter into force as a matter of urgency,

(1)

Regulation (EU) No 648/2012 has been amended by Regulation (EU) 2019/834 of the European Parliament and of the Council (2). Those amendments concerned, inter alia, the definition of financial counterparties, the right of access to the investigation file by persons subject an investigation, the fines to be paid by a trade repository that has, intentionally or negligently, committed one of the infringements listed in Annex I to Regulation (EU) No 648/2012, and the right of persons that may be subject to a periodic penalty payment to be heard.

(2)

Commission Delegated Regulation (EU) No 667/2014 (3) was adopted on the basis of Article 64(7) of Regulation (EU) No 648/2012 and deals with the rules of procedure for penalties imposed on trade repositories by the European Securities and Markets Authority (‘ESMA’), including rules on the right of defence. Since the amendments introduced by Regulation (EU) 2019/834 into Regulation (EU) No 648/2012 concern those rules of procedure, it is necessary to ensure that those amendments are also reflected in Delegated Regulation (EU) No 667/2014.

(3)

It is important that transparency is ensured between the investigation officer appointed by ESMA in accordance with Article 64 of Regulation (EU) No 648/2012 and ESMA itself. Such transparency requires that the investigation officer’s file contains the submissions made by persons subject to the investigation and the statement of findings on the basis on which those persons provided their submissions.

(4)

According to the second subparagraph of Article 67(1) of Regulation (EU) No 648/2012, ESMA has the possibility to adopt, where urgent action is needed, interim decisions without first hearing the persons subject to an investigation or proceedings. To ensure the effectiveness of ESMA’s power to adopt interim decisions, persons subject to an investigation should not have the right to access the file or to be heard before the investigation officer submits the file with his or her findings to ESMA or before ESMA adopts its interim decision. However, to respect the rights of defence, persons subject to an investigation should have the right to access the file as soon as the investigation officer has submitted the file with his or her statement of findings to ESMA and the right to be heard as soon as possible after ESMA has adopted its interim decision.

(5)

According to Article 68(5) of Regulation (EU) No 648/2012, the amounts corresponding to the fines and periodic penalty payments collected by ESMA are to be allocated to the general budget of the Union. Fines and periodic penalty payments collected by ESMA should be lodged to interest bearing accounts until they become final. For each decision imposing fines or periodic penalty payments, the amounts collected by ESMA should be lodged to a separate account or subaccount to ensure traceability until that decision becomes final.

(6)

Delegated Regulation (EU) No 667/2014 should be amended accordingly.

(7)

In the interest of the immediate exercise by ESMA of effective supervisory and enforcement powers, this Regulation should enter into force as a matter of urgency,

(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 authorisation.

(2)

Evonik Nutrition & Care GmbH has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation as regards Commission Implementing Regulation (EU) No 887/2011 (2), Commission Implementing Regulation (EU) 2017/961 (3) and Commission Implementing Regulation (EU) 2020/1395 (4).

(3)

The applicant claims that Evonik Nutrition & Care GmbH has changed their name to Evonik Operations GmbH. The application was accompanied by the relevant supporting data.

(4)

That proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned. The European Food and Safety Authority was informed of the application.

(5)

To allow the applicant to exploit its marketing rights under the name of Evonik Operations GmbH it is necessary to change the terms of the authorisation.

(6)

Implementing Regulation (EU) No 887/2011, Implementing Regulation (EU) 2017/961 and Implementing Regulation (EU) 2020/1395 should therefore be amended accordingly.

(7)

Since safety reasons do not require the immediate application of the amendment made by this Regulation to Implementing Regulation (EU) No 887/2011, Implementing Regulation (EU) 2017/961 and Implementing Regulation (EU) 2020/1395, it is appropriate to provide for a transitional period during which existing stocks may be used up.

(8)

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

(1)

On 30 January 2021, the Commission adopted Implementing Regulation (EU) 2021/111 (2) making the exportation of COVID-19 vaccines as well as active substances, including master and working cell banks, used to manufacture these vaccines, subject to the production of an export authorisation, pursuant to Article 5 of Regulation (EU) 2015/479. At the end of the six weeks period following the date of entry into force of those measures, the Commission adopted Implementing Regulation (EU) 2021/442 (3) making the exportation of the same products subject to an export authorisation until 30 June 2021, pursuant to Article 6 of Regulation (EU) 2015/479.

(2)

On 24 March 2021, the Commission adopted Implementing Regulation (EU) 2021/521 (4) introducing, as an additional factor to be taken into consideration when considering granting an export authorisation, the need to consider whether this authorisation does not pose a threat to the security of supply within the Union of the goods covered by Implementing Regulation (EU) 2021/442. By the same Implementing Regulation, the exemption of certain destination countries from the scope of Implementing Regulation (EU) 2021/442 was also temporarily suspended.

(3)

Implementing Regulation (EU) 2021/521 was adopted pursuant to Article 5 of Regulation (EU) 2015/479 and applies for a maximum period of six weeks.

(4)

Despite an acceleration of vaccination across the Union, the pandemic remains severe and the conditions described in the recitals of Implementing Regulation (EU) 2021/521 still persist.

(5)

The specific arrangements introduced by Implementing Regulation (EU) 2021/521 should therefore continue to apply until 30 June 2021.

(6)

Iceland, Liechtenstein and Norway (the EEA EFTA States) participate in the Union’s internal market in accordance with the Agreement on the European Economic Area. Most exports to the EEA EFTA States consist of vaccine procured by a Member State pursuant to an Advance Purchasing Agreement concluded by the Union and resold to those countries. On the basis of the information gathered through the application of Implementing Regulation (EU) 2021/521 there is no indication that exports are being channelled through the EEA EFTA States to other countries not exempted from the export authorization mechanism pursuant to Article 1(9) of Implementing Regulation (EU) 2021/442. Therefore, it is not necessary to continue the suspension of the exemption from that mechanism with regard to exports to the EEA EFTA States.

(7)

Implementing Regulation (EU) 2021/521 should therefore be amended accordingly and the amendment apply immediately.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 3(1) of Regulation (EU) 2015/479,

(1)

On 21 October 2020 the Irish Department of Agriculture, Food and the Marine (‘the competent authority’) adopted a decision in accordance with Article 55(1), first subparagraph, of Regulation (EU) No 528/2012 to permit the making available on the market for, and use by, professional users of the biocidal product Biobor JF for the preventive and curative antimicrobial treatment of aircraft fuel tanks and fuel systems until 19 April 2021 (‘the action’). The competent authority informed the Commission and the competent authorities of the other Member States about the action and the justification for it, in accordance with Article 55(1), second subparagraph, of that Regulation.

(2)

According to the information provided by the competent authority, the action was necessary in order to protect public health. The microbiological contamination of aircraft fuel tanks and fuel systems can lead to malfunctions of the aircraft engine and endanger its airworthiness, thus endangering the safety of passengers and crew. The COVID-19 pandemic and the ensuing flight restrictions led to numerous aircraft being temporarily parked. The immobility of aircraft is an aggravating factor of microbiological contamination.

(3)

Biobor JF contains 2,2’-(1-methyltrimethylenedioxy)bis-(4-methyl-1,3,2-dioxaborinane) (CAS number 2665-13-6) and 2,2’-oxybis (4,4,6-trimethyl-1,3,2-dioxaborinane) (CAS number 14697-50-8), active substances for use in biocidal products of product-type 6 as preservatives for products during storage as defined in Annex V to Regulation (EU) No 528/2012. As those active substances are not listed in Annex II to Commission Delegated Regulation (EU) No 1062/2014 (2), they are not included in the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012. Article 89 of that Regulation therefore does not apply to them and they have to be assessed and approved before biocidal products containing them can be authorised also at national level.

(4)

On 5 February 2021, the Commission received a reasoned request from the competent authority to extend the action in accordance with Article 55(1), third subparagraph, of Regulation (EU) No 528/2012. The reasoned request was made on the basis of concerns that air transport safety might continue to be endangered by microbiological contamination of aircraft fuel tanks and fuel systems after 19 April 2021 and the claim that Biobor JF is essential in order to control such microbiological contamination.

(5)

According to the information provided by the competent authority, the only alternative biocidal product recommended by aircraft and engine manufacturers for the treatment of microbiological contamination (Kathon™ FP 1.5) was withdrawn from the market in March 2020 due to engine behaviour anomalies noticed after the treatment with that product.

(6)

The mechanical treatment of microbiological contamination of aircraft fuel tanks and fuel systems is not always possible. Moreover, mechanical treatment would expose workers to toxic gases and should therefore be avoided.

(7)

According to the information available to the Commission, the manufacturer of Biobor JF has taken steps towards the regular authorisation of the product and an application for approval of the active substances it contains is expected to be submitted in the near future. The approval of the active substances and subsequent authorisation of the biocidal product would constitute a permanent solution for the future, but a significant amount of time would be needed for the completion of those procedures.

(8)

The lack of control of microbiological contamination of aircraft fuel tanks and fuel systems might endanger the air transport safety and that danger cannot be adequately contained by using another biocidal product or by other means. It is therefore appropriate to allow the competent authority to extend the action.

(9)

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

(1)

The European Union Aviation Safety Agency (‘EASA’) is empowered to conduct administrative inquiries, pre-disciplinary, disciplinary and suspension proceedings, in accordance with the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the European Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (‘Staff Regulations’) (3), and with Decision No 2011/216/E of EASA Executive Director of 16 December 2011 adopting implementing provisions regarding the conduct of administrative inquiries and disciplinary proceedings. If required, it also notifies cases to OLAF.

(2)

EASA staff members are under an obligation to report potentially illegal activities, including fraud and corruption, which are detrimental to the interests of the Union. Staff members are also obliged to report conduct relating to the discharge of professional duties which may constitute a serious failure to comply with the obligations of officials of the Union. This is regulated by EASA Management Board Decision 15-2018 of 14 December 2018.

(3)

EASA has put in place a policy to prevent and deal effectively with actual or potential cases of psychological or sexual harassment in the workplace, as provided for in EASA Decision No 2008/180/A of EASA Executive Director of 5 August 2009 adopting implementing measures pursuant to the Staff Regulations.

(4)

The Decision establishes an informal procedure whereby the alleged victim of the harassment can contact EASA’s ‘confidential’ counsellors.

(5)

EASA can also conduct investigations into potential breaches of security rules for European Union classified information (‘EUCI’), based on EASA Decision No 2020/010/ED of EASA Executive Director of 17 February 2020 on the EASA security rules on the protection of European Union Classified Information.

(6)

EASA is subject to both internal and external audits concerning its activities.

(7)

In the context of such administrative inquiries, audits and investigations, EASA cooperates with other Union institutions, bodies, offices and agencies.

(8)

EASA can cooperate with third countries’ national authorities and international organisations, either at their request or on its own initiative.

(9)

EASA can also cooperate with EU Member States’ public authorities, either at their request or on its own initiative.

(10)

EASA is involved in cases before the Court of Justice of the European Union when it either refers a matter to the Court, defends a decision it has taken and which has been challenged before the Court, or intervenes in cases relevant to its tasks. In this context, EASA might need to preserve the confidentiality of personal data contained in documents obtained by the parties or the interveners.

(11)

EASA is empowered to conduct inspections, other monitoring activities and investigations in compliance with Article 75(2)(e) of Regulation (EU) 2018/1139.

(12)

EASA is empowered to carry out IT security investigations handled internally or with external involvement (e.g. CERT-EU) in compliance with Article 75(2)(d) of Regulation (EU) 2018/1139.

(13)

The Data Protection Officer of EASA (‘DPO’) is empowered to process internal and external complaints and conduct internal audits and investigations in compliance with Article 45(2) of Regulation (EU) 2018/1725 (‘the Regulation’).

(14)

To fulfil its tasks, EASA collects and processes information and several categories of personal data, including identification data of natural persons, contact information, professional roles and tasks, information on private and professional conduct and performance, and financial data. EASA acts as data controller.

(15)

Under the Regulation, EASA is therefore obliged to provide information to data subjects on those processing activities and to respect their rights as data subjects.

(16)

EASA might be required to reconcile those rights with the objectives of administrative inquiries, audits, investigations and court proceedings. It might also be required to balance a data subject’s rights against the fundamental rights and freedoms of other data subjects. To that end, Article 25 of the Regulation gives EASA the possibility to restrict, under strict conditions, the application of Articles 14 to 22, 35 and 36 of the Regulation, as well as its Article 4 in so far as its provisions correspond to the rights and obligations provided for in Articles 14 to 20. Unless restrictions are provided for in a legal act adopted on the basis of the Treaties, it is necessary to adopt internal rules under which EASA is entitled to restrict those rights.

(17)

EASA might, for instance, need to restrict the information it provides to a data subject about the processing of his or her personal data during the preliminary assessment phase of an administrative inquiry or during the inquiry itself, prior to a possible dismissal of case or at the pre-disciplinary stage. In certain circumstances, providing such information might seriously affect EASA’s capacity to conduct the inquiry in an effective way, whenever, for example, there is a risk that the person concerned might destroy evidence or interfere with potential witnesses before they are interviewed. EASA might also need to protect the rights and freedoms of witnesses as well as those of other persons involved.

(18)

It might be necessary to protect the anonymity of a witness or whistle-blower who has asked not to be identified. In such a case, EASA might decide to restrict access to the identity, statements and other personal data of such persons, in order to protect their rights and freedoms.

(19)

It might be necessary to protect confidential information concerning a staff member who has contacted EASA confidential counsellors in the context of a harassment procedure. In such cases, EASA might need to restrict access to the identity, statements and other personal data of the alleged victim, the alleged harasser and other persons involved, in order to protect the rights and freedoms of all concerned.

(20)

EASA should apply restrictions only when they respect the essence of fundamental rights and freedoms, are strictly necessary and are a proportionate measure in a democratic society. EASA should give reasons explaining the justification for those restrictions.

(21)

In application of the principle of accountability, EASA should keep a record of its application of restrictions.

(22)

When processing personal data exchanged with other organisations in the context of its tasks, EASA and those organisations should consult each other on potential grounds for imposing restrictions and the necessity and proportionality of those restrictions, unless this would jeopardise the activities of EASA.

(23)

Article 25(6) of the Regulation obliges the controller to inform data subjects of the principal reasons on which the application of the restriction is based and of their right to lodge a complaint with the EDPS.

(24)

Pursuant to Article 25(8) of the Regulation, EASA is entitled to defer, omit or deny the provision of information on the reasons for the application of a restriction to the data subject if this would in any way cancel the effect of the restriction. EASA should assess on a case-by-case basis whether the communication of the restriction would cancel its effect.

(25)

EASA should lift the restriction as soon as the conditions that justify the restriction no longer apply, and assess those conditions on a regular basis.

(26)

To guarantee utmost protection of the rights and freedoms of data subjects and in accordance with Article 44(1) of the Regulation, the DPO should be consulted in due time of any restrictions that may be applied and verify their compliance with this Decision.

(27)

Articles 16(5) and 17(4) of the Regulation provide for exceptions to data subjects’ right to information and right of access. If these exceptions apply, EASA does not need to apply a restriction under this Decision,