(1)

The Union has set itself the objective of offering its citizens an area of freedom, security and justice without internal frontiers, in which the free movement of persons is ensured. At the same time, the Union should ensure that that area remains a safe place. That objective can only be achieved by more effective, coordinated cooperation of the national and international law enforcement and judicial authorities and by means of appropriate measures to prevent and combat crime, including organised crime and terrorism.

(2)

Achieving that objective is especially challenging where crime takes a cross-border dimension on the territory of two or more Member States and/or third countries. In such situations, Member States need to be able to join their forces and operations to allow for effective and efficient cross-border investigations and prosecutions, for which the exchange of information and evidence is crucial. One of the most successful tools for such cross-border cooperation is joint investigation teams (‘JITs’) that allow for direct cooperation and communication between the judicial and law enforcement authorities of two or more Member States and possibly third countries so that they can organise their actions and investigations in the most efficient manner. JITs are set up for a specific purpose and a limited period by the competent authorities of two or more Member States and possibly third countries, to carry out criminal investigations with a cross-border impact jointly.

(3)

JITs have proven instrumental in improving judicial cooperation in relation to the investigation and prosecution of cross-border crimes, such as cybercrime, terrorism, and serious and organised crime, by reducing time-consuming procedures and formalities between JIT members. The increased use of JITs has also enhanced the culture of cross-border cooperation in criminal matters between judicial authorities in the Union.

(4)

The Union acquis provides for two legal frameworks to set up JITs with the participation of at least two Member States: Article 13 of the Convention established by the Council in accordance with Article 34 of the Treaty on European Union, on Mutual Assistance in Criminal Matters between the Member States of the European Union (2) and Council Framework Decision 2002/465/JHA (3). Third countries can be involved in JITs as Parties where there is a legal basis for such involvement, such as Article 20 of the Second Additional Protocol to the European Convention on Mutual Assistance in Criminal Matters, signed in Strasbourg on 8 November 2001 (4) and Article 5 of the Agreement on mutual legal assistance between the European Union and the United States of America (5).

(5)

International judicial authorities play a crucial role in the investigation and prosecution of international crimes. Their representatives may participate in a particular JIT on invitation of the JIT members based on the relevant agreement setting up a JIT (‘JIT agreement’). Therefore, the exchange of information and evidence between national competent authorities and any other court, tribunal or mechanism that aims to address serious crimes of concern to the international community as a whole, in particular the International Criminal Court (ICC), should be facilitated as well. This Regulation should therefore provide access to the Information Technology (IT) platform (‘JITs collaboration platform’) for representatives of such international judicial authorities in order to enhance international cooperation in relation to the investigation and prosecution of international crimes.

(6)

There is a pressing need for a collaboration platform for JITs to communicate efficiently and to exchange information and evidence in a secure manner in order to ensure that those responsible for the gravest crimes can be swiftly held responsible. That need is underlined by the mandate of the European Union Agency for Criminal Justice Cooperation (Eurojust) established by Regulation (EU) 2018/1727 of the European Parliament and of the Council (6), which was amended by Regulation (EU) 2022/838 of the European Parliament and of the Council (7), enabling Eurojust to preserve, analyse and store evidence relating to genocide, crimes against humanity, war crimes and related criminal offences and enabling the exchange of related evidence with competent national authorities and international judicial authorities, in particular the ICC.

(7)

The existing legal frameworks at Union level do not set out how the entities that participate in a JIT are to exchange information and communicate. Those entities reach an agreement on such exchange and communication on the basis of needs and available means. To fight increasingly complex and fast-evolving cross-border crime, speed, cooperation and efficiency are crucial. However, there is currently no system to support the management of JITs, to allow for more efficient evidence searching and recording, and to secure the data exchanged between those involved in a JIT. There is an evident lack of dedicated secure and effective channels to which all those involved in a JIT could have recourse and through which they could promptly exchange large volumes of information and evidence or allow for secure and effective communication. Furthermore, there is no system to support either the management of JITs, including the traceability of evidence exchanged among those involved in a JIT in a manner that is compliant with legal requirements before national courts, or the planning and coordination of operations of a JIT.

(8)

In light of the increasing possibilities of crime infiltrating IT systems, the current state of play could hamper the effectiveness and efficiency of cross-border investigations, as well as jeopardise and slow down such investigations and prosecutions due to the insecure and non-digital exchange of information and evidence, thereby making them more costly. The judicial and law enforcement authorities in particular need to ensure that their systems are as modern and as safe as possible and that all JIT members can connect and interact easily, independently of their national systems.

(9)

It is important for JIT cooperation to be improved and supported by modern IT tools. The speed and efficiency of the exchanges between those involved in a JIT could be considerably enhanced by creating a dedicated IT platform to support the functioning of JITs. Therefore, it is necessary to lay down rules establishing a JITs collaboration platform at Union level in order to help those involved in a JIT to collaborate, securely communicate and share information and evidence.

(10)

The JITs collaboration platform should only be used where there is, inter alia, a Union legal basis for the setting up of a JIT. For all JITs set up solely on international legal bases, the JITs collaboration platform should not be used, since it is financed by the Union budget and developed on the basis of Union legislation. However, where the competent authorities of a third country are a Party to a JIT agreement that has a Union legal basis as well as an international one, the representatives of the competent authorities of that third country should be considered to be JIT members.

(11)

The use of the JITs collaboration platform should be on a voluntary basis. However, in view of its added value for cross-border investigations, its use is strongly encouraged. The use or non-use of the JITs collaboration platform should not prejudice or affect the legality of other forms of communication or exchange of information, nor should it change the way in which the JITs are set up, are organised or function. The establishment of the JITs collaboration platform should not have an impact on the underlying legal bases for the setting up of JITs, nor should it affect the applicable national procedural legislation regarding the collection and use of the obtained evidence. Officials from other national competent authorities, such as customs, where they are members of JITs set up pursuant to Framework Decision 2002/465/JHA, should be able to have access to the JIT collaboration spaces. The JITs collaboration platform should only provide a secure IT tool to improve cooperation, accelerate the flow of information between its users and increase the security of the data exchanged and the effectiveness of the JITs.

(12)

The JITs collaboration platform should cover the operational and post-operational phases of a JIT from the moment that the relevant JIT agreement is signed until the JIT evaluation has been completed. Due to the fact that the actors participating in the JIT set-up process are different from the actors who are members of a JIT once it is established, the process of setting up a JIT, especially the negotiation of the content and the signature of the JIT agreement, should not be managed through the JITs collaboration platform. However, given the need for an electronic tool to support the process of signing a JIT agreement, it is important for the Commission to consider covering that process by the e-Evidence Digital Exchange System (eEDES), which is a secure online portal for electronic requests and responses developed by the Commission.

(13)

For each JIT that uses the JITs collaboration platform, the JIT members should be encouraged to conduct an evaluation of the JIT, either during the operational phase of the JIT or following its closure, using the tools provided for by the JITs collaboration platform.

(14)

A JIT agreement, including any appendices, should be a prerequisite for the use of the JITs collaboration platform. The content of all future JIT agreements should be adapted to take into account the relevant provisions of this Regulation.

(15)

The network of national experts on JITs, which was formed in 2005 (‘JITs Network’), developed a model agreement which includes appendices, in order to facilitate the setting up of JITs. The content of the model agreement and its appendices should be adapted to take into account the decision to use the JITs collaboration platform and the rules for access to the JITs collaboration platform.

(16)

From an operational perspective, the JITs collaboration platform should be composed of isolated JIT collaboration spaces created for each individual JIT hosted by the JITs collaboration platform.

(17)

From a technical perspective, the JITs collaboration platform should be accessible via a secure connection over the internet and should be composed of a centralised information system, accessible through a secure web portal, communication software for mobile and desktop devices, including an advanced logging and tracking mechanism, and a connection between the centralised information system and the relevant IT tools that support the functioning of JITs and that are managed by the JITs Network Secretariat.

(18)

The purpose of the JITs collaboration platform should be to facilitate the coordination and management of a JIT. The JITs collaboration platform should ensure the exchange and temporary storage of operational information and evidence, provide secure communication, provide for evidence traceability and support the process of the evaluation of a JIT. All those involved in a JIT should be encouraged to use all functionalities of the JITs collaboration platform and to replace insofar as possible the communication and data exchange channels which are currently used with those of the JITs collaboration platform.

(19)

The coordination and exchange of data between Union agencies and bodies in the area of freedom, security and justice that are involved in judicial cooperation and JIT members is key in ensuring a coordinated Union response to criminal activities and in providing crucial support to Member States in tackling crime. The JITs collaboration platform should complement existing tools that allow for the secure exchange of data among judicial and law enforcement authorities, such as the Secure Information Exchange Network Application (SIENA) managed by the European Union Agency for Law Enforcement Cooperation (Europol) established by Regulation (EU) 2016/794 of the European Parliament and of the Council (8).

(20)

Communication-related functionalities of the JITs collaboration platform should be provided by state-of-the-art software that allows for non-traceable communication to be stored locally on the devices of the JITs collaboration platform users.

(21)

A proper functionality that allows the exchange of operational information and evidence, including large files, should be ensured through an upload/download mechanism designed to store the data centrally only for the limited period of time necessary for the technical transfer of the data. As soon as the data are downloaded by all addressees, they should be automatically and permanently erased from the JITs collaboration platform.

(22)

Given its experience with managing large-scale systems in the area of justice and home affairs, the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) established by Regulation (EU) 2018/1726 of the European Parliament and of the Council (9) should be entrusted with the task of designing, developing and operating the JITs collaboration platform, making use of the existing functionalities of SIENA and other functionalities at Europol to ensure complementarity and, where appropriate, connectivity. Therefore, eu-LISA’s mandate should be amended to reflect those new tasks and eu-LISA should be provided with the appropriate funding and staffing to meet its responsibilities under this Regulation. In that regard, rules should be established on the responsibilities of eu-LISA, as the agency entrusted with the development, technical operation and maintenance of the JITs collaboration platform.

(23)

eu-LISA should ensure that data held by law enforcement authorities could, where necessary, easily be transmitted from SIENA to the JITs collaboration platform. To that end, a report should be submitted by the Commission to the European Parliament and to the Council assessing the necessity, feasibility and suitability of a connection of the JITs collaboration platform with SIENA. That report should contain the conditions, technical specifications and procedures that ensure a secure and efficient connection and data exchange. The assessment should take into account the high level of data protection needed for such a connection, based on the existing Union and national data protection legal framework, such as Directive (EU) 2016/680 of the European Parliament and of the Council (10), Regulation (EU) 2018/1725 of the European Parliament and of the Council (11) and the rules applicable to relevant Union bodies, offices or agencies in the legal acts establishing them. The protection level of data that will be exchanged through the JITs collaboration platform, namely sensitive and non-classified data, should be taken into account. In accordance with Regulation (EU) 2018/1725, the Commission should also consult the European Data Protection Supervisor prior to submitting that report to the European Parliament and Council with regard to the impact on the protection of individuals’ rights and freedoms stemming from the envisaged processing of personal data.

(24)

Since the formation of the JITs Network in 2005, the JITs Network Secretariat supports the work of the JITs Network by organising annual meetings and training activities, by collecting and analysing evaluations of the individual JITs and by managing Eurojust’s JIT funding programme. Since 2011, the JITs Network Secretariat has been hosted by Eurojust as a separate unit. Eurojust should be provided with appropriate staff allocated to the JITs Network Secretariat in order to allow the JITs Network Secretariat to support JITs collaboration platform users in the practical application of the JITs collaboration platform, to provide day-to-day guidance and assistance, to design and provide training courses and to raise awareness and promote the use of the JITs collaboration platform.

(25)

Given the currently existing IT tools supporting operations of JITs, which are hosted at Eurojust and managed by the JITs Network Secretariat, it is necessary to connect the JITs collaboration platform with those IT tools, in order to facilitate the management of JITs. To that end, Eurojust should ensure the necessary technical adaptation of its systems in order to establish such a connection. Eurojust should also be provided with the appropriate funding and staffing to meet its responsibilities in that regard.

(26)

During the operational phase of a JIT, Eurojust and Europol provide valuable operational support to JIT members by offering a wide range of supporting tools, including mobile offices, cross-match and analytical analyses, coordination and operational centres, the coordination of prosecution, expertise and funding.

(27)

In order to ensure a clear division of rights and tasks, rules should be established on the responsibilities of Member States, Eurojust, Europol, the European Public Prosecutor’s Office (‘the EPPO’) established by Council Regulation (EU) 2017/1939 (12), the European Anti-Fraud Office (OLAF) established by Commission Decision 1999/352/EC, ECSC, Euratom (13) and other competent Union bodies, offices and agencies, including the conditions under which they may use the JITs collaboration platform for operative purposes.

(28)

This Regulation sets out the details regarding the mandate, composition and organisational aspects of a Programme Management Board which should be established by the Management Board of eu-LISA. The Programme Management Board should ensure adequate management of the design and development phase of the JITs collaboration platform. It is also necessary to set out the details of the mandate, composition and organisational aspects of an Advisory Group to be established by eu-LISA in order to obtain expertise related to the JITs collaboration platform, in particular in the context of the preparation of eu-LISA’s annual work programme and annual activity report.

(29)

This Regulation establishes rules on access to the JITs collaboration platform and the necessary safeguards. The JIT space administrator or administrators should be entrusted with the management of access rights to the individual JIT collaboration spaces. They should be in charge of managing access, during the operational and post-operational phases of the JIT, for JITs collaboration platform users, on the basis of the relevant JIT agreement. JIT space administrators should be able to delegate their technical and administrative tasks to the JITs Network Secretariat, except for verification of the data uploaded by third countries or representatives of international judicial authorities.

(30)

Bearing in mind the sensitivity of the operational data exchanged among the JITs collaboration platform users, the JITs collaboration platform should ensure a high level of security. eu-LISA should take all necessary technical and organisational measures in order to ensure the security of the exchange of data by using strong end-to-end encryption algorithms to encrypt data in transit or at rest.

(31)

This Regulation establishes rules on the liability of Member States, eu-LISA, Eurojust, Europol, the EPPO, OLAF and other competent Union bodies, offices and agencies, in respect of material or non-material damage occurring as a result of any act incompatible with this Regulation. Concerning third countries and international judicial authorities, liability clauses in respect of material or non-material damage should be contained in the relevant JIT agreements.

(32)

This Regulation lays down specific data protection provisions that concern both operational data and non-operational data. Those data protection provisions are required in order to supplement the existing data protection arrangements and to provide for an adequate overall level of data protection, data security and protection of the fundamental rights of the persons concerned.

(33)

The processing of personal data under this Regulation should comply with the Union’s legal framework on the protection of personal data. Directive (EU) 2016/680 applies to the processing of personal data by competent national authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security. As regards the processing of data by Union institutions, bodies, offices and agencies, Regulation (EU) 2018/1725 applies in the context of this Regulation. To that end, appropriate data protection safeguards should be ensured.

(34)

Each competent national authority of a Member State and, where appropriate, Eurojust, Europol, the EPPO, OLAF or any other competent Union body, office or agency, should be individually responsible for the processing of operational personal data when using the JITs collaboration platform. JITs collaboration platform users should be considered joint controllers, within the meaning of Regulation (EU) 2018/1725, for the processing of non-operational personal data.

(35)

In accordance with the relevant JIT agreement, it should be possible for JIT space administrators to grant access to a JIT collaboration space to representatives of competent authorities of third countries which are Parties to a JIT agreement or to representatives of international judicial authorities who participate in a JIT. In the context of a JIT agreement, any transfer of personal data to third countries or international judicial authorities, those authorities being considered international organisations for that purpose, is subject to compliance with the provisions set out in Chapter V of Directive (EU) 2016/680. Exchanges of operational data with third countries or international judicial authorities should be limited to those strictly required to fulfil the purposes of the relevant JIT agreement.

(36)

Where a JIT has multiple JIT space administrators, one of them should be designated in the relevant JIT agreement as controller of the data uploaded by third countries or representatives of international judicial authorities, before the JIT collaboration space in which third countries or representatives of international judicial authorities are involved is created.

(37)

eu-LISA should ensure that accessing the centralised information system and all data processing operations in the centralised information system are logged for the purposes of monitoring data integrity and security and the lawfulness of the data processing, as well as for the purposes of self-monitoring. eu-LISA should not have access to operational and non-operational data stored in the JIT collaboration spaces.

(38)

This Regulation imposes reporting obligations on eu-LISA regarding the development and functioning of the JITs collaboration platform in light of objectives relating to the planning, technical output, cost-effectiveness, security and quality of service. Furthermore, the Commission should conduct an overall evaluation of the JITs collaboration platform that takes into account the objectives of this Regulation, as well as the aggregated results of the evaluations of the individual JITs, not later than two years after the start of operations of the JITs collaboration platform and every four years thereafter.

(39)

While the cost of setting up and maintenance of the JITs collaboration platform and the supporting role of Eurojust after the start of operations of the JITs collaboration platform should be borne by the Union budget, each Member State, as well as Eurojust, Europol, the EPPO, OLAF and any other competent Union body, office and agency, should bear its own costs that arise from its use of the JITs collaboration platform.

(40)

In order to establish uniform conditions for the technical development and implementation of the JITs collaboration platform, 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 the Council (14).

(41)

The Commission should adopt the relevant implementing acts necessary for the technical development of the JITs collaboration platform as soon as possible after the date of entry into force of this Regulation.

(42)

The Commission should determine the date of the start of operations of the JITs collaboration platform once the relevant implementing acts necessary for the technical development of the JITs collaboration platform have been adopted and eu-LISA has carried out a comprehensive test of the JITs collaboration platform, with the involvement of the Member States.

(43)

Since the objective of this Regulation, namely to enable the effective and efficient cooperation, communication and exchange of information and evidence among JIT members, representatives of international judicial authorities, Eurojust, Europol, OLAF and other competent Union bodies, offices and agencies, cannot be sufficiently achieved by the Member States, but can rather, by setting out common rules, 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 Regulation does not go beyond what is necessary to achieve that objective.

(44)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the Treaty on the Functioning of the European Union (TFEU), Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application.

(45)

In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, Ireland has notified, by letter of 7 April 2022, its wish to take part in the adoption and application of this Regulation.

(46)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered formal comments on 25 January 2022,

(1)

Article 11 of the United Nations Convention of 18 December 1979 on the Elimination of All Forms of Discrimination against Women, which all Member States have ratified, provides that States Parties are to take all appropriate measures to ensure, inter alia, the right to equal remuneration, including benefits, and to equal treatment in respect of work of equal value, as well as equality of treatment in the evaluation of the quality of work.

(2)

Article 2 and Article 3(3) of the Treaty on European Union enshrine the right to equality between women and men as one of the essential values of the Union.

(3)

Articles 8 and 10 of the Treaty on the Functioning of the European Union (TFEU) require the Union to aim to eliminate inequalities, to promote equality between men and women and to combat discrimination based on sex in all its policies and activities.

(4)

Article 157(1) TFEU obliges each Member State to ensure that the principle of equal pay for male and female workers for equal work or work of equal value is applied. Article 157(3) TFEU provides for the adoption by the Union of measures to ensure the application of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation, including the principle of equal pay for equal work or work of equal value (the ‘principle of equal pay’).

(5)

The Court of Justice of the European Union (the ‘Court of Justice’) has held that the scope of the principle of equal treatment of men and women cannot be confined to discrimination based on the fact that a person is of one or other sex (3). In view of its purpose and the nature of the rights which it seeks to safeguard, that principle also applies to discrimination arising from gender reassignment.

(6)

In some Member States, it is currently possible for persons to legally register as having a third, often a neutral, gender. This Directive does not affect relevant national rules giving effect to such recognition as regards matters of employment and pay.

(7)

Article 21 of the Charter of Fundamental Rights of the European Union (the ‘Charter’) prohibits any discrimination, inter alia, on the grounds of sex. Article 23 of the Charter provides that equality between women and men must be ensured in all areas, including employment, work and pay.

(8)

Article 23 of the Universal Declaration of Human Rights states, inter alia, that everyone, without any discrimination, has the right to equal pay for equal work, to free choice of employment, to just and favourable conditions of work and to just remuneration ensuring an existence worthy of human dignity.

(9)

The European Pillar of Social Rights, jointly proclaimed by the European Parliament, the Council, and the Commission, incorporates among its principles equality of treatment and opportunities between women and men, and the right to equal pay for work of equal value.

(10)

Directive 2006/54/EC of the European Parliament and of the Council (4) provides that for the same work or for work to which equal value is attributed, direct and indirect discrimination on grounds of sex with regard to all aspects and conditions of remuneration is to be eliminated. In particular, where a job classification system is used for determining pay, it is to be based on the same gender-neutral criteria and should be drawn up so as to exclude any discrimination on grounds of sex.

(11)

The 2020 evaluation of the relevant provisions of Directive 2006/54/EC found that the application of the principle of equal pay is hindered by a lack of transparency in pay systems, a lack of legal certainty on the concept of work of equal value, and by procedural obstacles faced by victims of discrimination. Workers lack the necessary information to make a successful equal pay claim and, in particular, information about the pay levels for categories of workers who perform the same work or work of equal value. The report found that increased transparency would allow revealing gender bias and discrimination in the pay structures of an undertaking or organisation. It would also enable workers, employers and the social partners to take appropriate action to ensure the application of the right to equal pay for equal work and work of equal value (the ‘right to equal pay’).

(12)

Following a thorough evaluation of the existing framework on equal pay for equal work or work of equal value and a wide-ranging and inclusive consultation process, the Communication of the Commission of 5 March 2020 on ‘A Union of Equality: Gender Equality Strategy 2020-2025’ announced that the Commission would propose binding measures on pay transparency.

(13)

The economic and social consequences of the COVID-19 pandemic have had a disproportionately negative impact on women and gender equality, and job losses have often been concentrated in low-paid, female-dominated sectors. The COVID-19 pandemic has highlighted the continued, structural undervaluation of work predominantly carried out by women and has demonstrated the high socio-economic value of women’s work in front-line services, such as health care, cleaning, childcare, social care and residential care for older people and other adult dependents, which stands in strong contrast to its low visibility and recognition.

(14)

The effects of the COVID-19 pandemic will therefore further widen gender inequalities and the gender pay gap unless the recovery response is gender sensitive. Those consequences have made it even more pressing to tackle the issue of equal pay for equal work or work of equal value. Strengthening the implementation of the principle of equal pay through further measures is particularly important to ensure that the progress which has been made in addressing disparities in pay is not compromised.

(15)

The Union gender pay gap persists: it stood at 13 % in 2020, with significant variations across Member States, and has decreased only minimally over the last ten years. The gender pay gap is caused by various factors, such as gender stereotypes, the perpetuation of the ‘glass ceiling’ and the ‘sticky floor’, horizontal segregation, including the overrepresentation of women in low-paid service jobs, and unequal sharing of care responsibilities. In addition, the gender pay gap is partly caused by direct and indirect gender-based pay discrimination. All those elements constitute structural obstacles that form complex challenges to achieving good quality jobs and equal pay for equal work or work of equal value and have long-term consequences such as a pension gap and the feminisation of poverty.

(16)

A general lack of transparency about pay levels within organisations maintains a situation where gender-based pay discrimination and bias can go undetected or, where suspected, are difficult to prove. Binding measures are therefore needed to improve pay transparency, encourage organisations to review their pay structures to ensure equal pay for women and men performing the same work or work of equal value, and to enable victims of discrimination to exercise their right to equal pay. Such binding measures need to be complemented by provisions clarifying existing legal concepts, such as the concepts of pay and work of equal value, and measures improving enforcement mechanisms and access to justice.

(17)

The application of the principle of equal pay should be enhanced by eliminating direct and indirect pay discrimination. This does not preclude employers from paying workers performing the same work or work of equal value differently on the basis of objective, gender-neutral and bias-free criteria, such as performance and competence.

(18)

This Directive should apply to all workers, including part-time workers, workers on a fixed-term contract and persons with a contract of employment or employment relationship with a temporary agency, as well as workers in management positions, who have an employment contract or employment relationship as defined by law, collective agreements and/or practice in force in each Member State, taking into account the case-law of the Court of Justice (5). Provided that they fulfil relevant criteria, domestic workers, on-demand workers, intermittent workers, voucher based-workers, platform workers, workers in sheltered employment, trainees and apprentices fall within the scope of this Directive. The determination of the existence of an employment relationship should be guided by the facts relating to the actual performance of the work and not by the parties’ description of the relationship.

(19)

An important element of eliminating pay discrimination is pay transparency prior to employment. This Directive should therefore also apply to applicants for employment.

(20)

In order to remove obstacles for victims of gender-based pay discrimination to exercise their right to equal pay, and to guide employers in ensuring respect of that right, the core concepts related to equal pay for equal work or work of equal value, such as pay and work of equal value, should be clarified in accordance with the case-law of the Court of Justice. This should facilitate the application of those concepts, especially for micro, small and medium-sized enterprises.

(21)

The principle of equal pay should be observed with regard to wages, salaries or any other consideration, whether in cash or in kind, which workers receive directly or indirectly, in respect of their employment from their employer. In accordance with the case-law of the Court of Justice (6), the concept of pay should comprise not only salary, but also complementary or variable components of the pay. Under complementary or variable components, any benefits in addition to the ordinary basic or minimum wage or salary, which the worker receives directly or indirectly, whether in cash or in kind, should be taken into account. Such complementary or variable components may include, but are not limited to, bonuses, overtime compensation, travel facilities, housing and food allowances, compensation for attending training, payments in the case of dismissal, statutory sick pay, statutory required compensation and occupational pensions. The concept of pay should include all elements of remuneration due under law, collective agreements and/or practice in each Member State.

(22)

In order to ensure a uniform presentation of the information required by this Directive, pay levels should be expressed as gross annual pay and the corresponding gross hourly pay. It should be possible to base the calculation of pay levels on the actual pay specified in regard to the worker, regardless of whether it is set annually, monthly, hourly or otherwise.

(23)

Member States should not be obliged to set up new bodies for the purpose of this Directive. It should be possible for them to confer tasks deriving from it upon established bodies, including the social partners, in accordance with national law and/or practice, provided that the Member States comply with the obligations set out in this Directive.

(24)

In order to protect workers and to address their fear of victimisation in the application of the principle of equal pay, they should be able to be represented by a representative. This could be trade unions or other workers’ representatives. If there are no workers’ representatives, workers should be able to be represented by a representative of their choice. Member States should have a possibility to take into account their national circumstances and different roles concerning workers’ representation.

(25)

Article 10 TFEU provides that, in defining and implementing its policies and activities, the Union is to aim to combat discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. Article 4 of Directive 2006/54/EC provides that there is to be no direct or indirect discrimination on grounds of sex in relation to pay. Gender-based pay discrimination where a victim’s sex plays a crucial role can take many different forms in practice. It may involve an intersection of various axes of discrimination or inequality where the worker is a member of one or several groups protected against discrimination on the basis of sex, on the one hand, and racial or ethnic origin, religion or belief, disability, age or sexual orientation, as protected under Council Directive 2000/43/EC (7) or 2000/78/EC (8), on the other. Women with disabilities, women of diverse racial and ethnic origin including Roma women, and young or elderly women are among groups which may face intersectional discrimination. This Directive should therefore clarify that, in the context of gender-based pay discrimination, it should be possible to take such a combination into account, thus removing any doubt that may exist in this regard under the existing legal framework and enabling national courts, equality bodies and other competent authorities to take due account of any situation of disadvantage arising from intersectional discrimination, in particular for substantive and procedural purposes, including to recognise the existence of discrimination, to decide on the appropriate comparator, to assess the proportionality, and to determine, where relevant, the level of compensation awarded or penalties imposed.

An intersectional approach is important for understanding and addressing the gender pay gap. This clarification should not change the scope of employers’ obligations in regard to the pay transparency measures under this Directive. In particular, employers should not be required to gather data related to protected grounds other than sex.

(26)

In order to respect the right to equal pay, employers must have pay structures in place ensuring that there are no gender-based pay differences between workers performing the same work or work of equal value that are not justified on the basis of objective, gender-neutral criteria. Such pay structures should allow for the comparison of the value of different jobs within the same organisational structure. It should be possible to base such pay structures on existing Union guidelines related to gender-neutral job evaluation and classification systems, or on indicators or gender-neutral models. In accordance with the case law of the Court of Justice, the value of work should be assessed and compared on the basis of objective criteria, including educational, professional and training requirements, skills, effort, responsibility and working conditions, irrespective of differences in working patterns. To facilitate the application of the concept of work of equal value, especially for micro, small and medium-sized enterprises, the objective criteria to be used should include four factors: skills, effort, responsibility and working conditions. Those factors have been identified by the existing Union guidelines as being essential and sufficient for evaluating the tasks performed in an organisation regardless of to which economic sector the organisation belongs.

As not all factors are equally relevant for a specific position, each of the four factors should be weighed by the employer depending on the relevance of those criteria for the specific job or position concerned. Additional criteria may also be taken into account, where they are relevant and justified. Where appropriate, the Commission should be able to update existing Union guidelines, in consultation with the European Institute for Gender Equality (EIGE).

(27)

National systems for wage-setting vary and can be based on collective agreements and/or elements decided by the employer. This Directive does not affect the various national systems for wage setting.

(28)

The identification of a valid comparator is an important parameter in determining whether work may be considered of equal value. It enables workers to show that they were treated less favourably than a comparator of a different sex performing equal work or work of equal value. Building on the developments brought by the definition of direct and indirect discrimination in Directive 2006/54/EC, in situations where no real-life comparator exists, the use of a hypothetical comparator should be allowed, to enable workers to show that they have not been treated in the same way as a hypothetical comparator of another sex would have been treated. This would lift an important obstacle for potential victims of gender-based pay discrimination, especially in highly gender-segregated employment markets where a requirement of finding a comparator of the opposite sex makes it almost impossible to bring an equal pay claim.

In addition, workers should not be prevented from using other facts from which an alleged discrimination can be presumed, such as statistics or other available information. This would allow gender-based pay inequalities to be more effectively addressed in gender-segregated sectors and professions, especially in female-dominated ones such as the care sector.

(29)

The Court of Justice has clarified that in order to assess whether workers are in a comparable situation, the comparison is not necessarily limited to situations in which men and women work for the same employer (9). Workers may be in a comparable situation even when they do not work for the same employer whenever the pay conditions can be attributed to a single source establishing those conditions and where those conditions are equal and comparable. This may be the case when the relevant pay conditions are regulated by statutory provisions or agreements relating to pay applicable to several employers, or when such conditions are laid down centrally for more than one organisation or business within a holding company or conglomerate. Furthermore, the Court of Justice has clarified that the comparison is not limited to workers employed at the same time as the claimant (10). Additionally, when performing the actual assessment, it should be recognised that a difference in pay may be explained by factors unrelated to sex.

(30)

Member States should ensure that training and specific tools and methodologies are made available to support and guide employers in the assessment of what constitutes work of equal value. This should facilitate the application of that concept, especially for micro, small and medium-sized enterprises. Taking into account national law, collective agreements and/or practice, Member States should be able to entrust the development of specific tools and methodologies to the social partners or develop them in cooperation with, or after consulting, the social partners.

(31)

Job classification and evaluation systems can, if not used in a gender-neutral manner, in particular when they assume traditional gender stereotypes, result in gender-based pay discrimination. In such cases, they contribute to and perpetuate the pay gap by evaluating male and female dominated jobs differently in situations where the work performed is of equal value. Where gender-neutral job evaluation and classification systems are used, however, they are effective in establishing a transparent pay system and are instrumental in ensuring that direct or indirect discrimination on grounds of sex is excluded. They detect indirect pay discrimination related to the undervaluation of jobs typically done by women. They do so by measuring and comparing jobs the content of which is different but of equal value and so support the principle of equal pay.

(32)

The lack of information on the envisaged pay range of a position creates an information asymmetry which limits the bargaining power of applicants for employment. Ensuring transparency should enable prospective workers to make an informed decision about the expected salary without limiting in any way the employer’s or worker’s bargaining power to negotiate a salary even outside the indicated range. Transparency would also ensure an explicit, non-gender-biased basis for pay setting and would disrupt the undervaluation of pay compared to skills and experience. Transparency would also address intersectional discrimination where non-transparent pay settings allow for discriminatory practices on several discrimination grounds. Applicants for employment should receive information about the initial pay or its range in a manner such as to ensure an informed and transparent negotiation on pay, such as in a published job vacancy notice, prior to the job interview, or otherwise prior to the conclusion of any employment contract. The information should be provided by the employer or in a different manner, for instance by the social partners.

(33)

In order to disrupt the perpetuation of the gender pay gap affecting individual workers over time, employers should ensure that job vacancy notices and job titles are gender neutral and that recruitment processes are led in a non-discriminatory manner, so as not to undermine the right to equal pay. Employers should not be allowed to enquire or proactively try to obtain information about the current pay or prior pay history of an applicant for employment.

(34)

Pay transparency measures should protect workers’ right to equal pay while limiting, to the extent possible, costs and administrative burden for employers, paying specific attention to micro, small and medium-sized enterprises. Where appropriate, measures should be tailored to the size of employers, taking into account employers’ headcount. The number of workers employed by employers to be applied as a criterion whether an employer is subject to pay reporting as referred to in this Directive is set taking into account Commission Recommendation 2003/361/EC on micro, small and medium-sized enterprises (11).

(35)

Employers should make accessible to workers the criteria that are used to determine pay levels and pay progression. Pay progression refers to the process of how a worker moves to a higher pay level. Criteria related to pay progression can include, inter alia, individual performance, skills development and seniority. When implementing this obligation, Member States should pay particular attention to avoiding excessive administrative burden for micro and small enterprises. Member States should also be able to provide, as a mitigating measure, ready-made templates to support micro and small enterprises in complying with the obligation. Member States should be able to exempt employers which are micro or small enterprises from the obligation related to pay progression, for instance by allowing them to make the pay progression criteria available upon request by workers.

(36)

All workers should have the right to obtain information, upon their request, on their individual pay level and on the average pay levels, broken down by sex, for the category of workers performing the same work as them or work of equal value to theirs. They should also have the possibility to receive the information through workers’ representatives or through an equality body. Employers should inform workers of that right on an annual basis, as well as of the steps to be undertaken in order to exercise the right. Employers may also, on their own initiative, opt to provide such information without workers needing to request it.

(37)

This Directive should ensure that persons with disabilities have adequate access to the information provided pursuant to it to applicants for employment and workers. Such information should be provided to those persons taking into account their particular disabilities, in a format and appropriate form of assistance and support to ensure their access to and comprehension of the information. This could include the provision of information in an understandable way which they can perceive, in fonts of adequate size, using sufficient contrast or other format appropriate to the type of their disability. Where relevant, Directive (EU) 2016/2102 of the European Parliament and of the Council (12) applies.

(38)

Employers with at least 100 workers should regularly report on pay, as provided for by this Directive. That information should be published by the Member States’ monitoring bodies in a suitable and transparent manner. Employers may publish those reports on their website or make them publicly available in another manner, for instance by including the information in their management report, where applicable in the management report drawn up under Directive 2013/34/EU of the European Parliament and of the Council (13). Employers that are subject to the requirements of that Directive may choose to report on pay alongside other worker-related matters in their management report. To maximise the coverage of pay transparency of workers, Member States may increase the frequency of reporting or make regular reporting on pay mandatory for employers with fewer than 100 workers.

(39)

Pay reporting should allow employers to evaluate and monitor their pay structures and policies, allowing them to proactively comply with the principle of equal pay. Reporting and joint pay assessments contribute to an increased awareness of gender bias in pay structures and of pay discrimination and contribute to addressing such bias and discrimination in an effective and systemic way, thereby benefitting all workers employed by the same employer. At the same time, the sex-disaggregated data should assist competent public authorities, workers’ representatives and other stakeholders in monitoring the gender pay gap across sectors (horizontal segregation) and functions (vertical segregation). Employers may wish to accompany the published data by an explanation of any gender pay differences or gaps. Where differences in average pay for the same work or work of equal value between female and male workers are not justified on the basis of objective, gender-neutral criteria, the employer should take measures to remove the inequalities.

(40)

To reduce the burden on employers, Member States could gather and interlink the necessary data through their national administrations allowing for a computation of the pay gap between female and male workers per employer. Such data gathering may require interlinking data from several public administrations, such as tax inspectorates and social security offices, and would be possible if administrative data matching employers’ data, at company or organisational level, to workers’ data, at individual level, including benefits in cash and in kind, are available. Member States could gather that information not only for employers that are covered by the pay reporting obligation under this Directive, but also for employers that are not covered by the obligation and that report voluntarily. The publication of the required information by Member States should replace the obligation of pay reporting on those employers covered by the administrative data provided that the result intended by the reporting obligation is achieved.

(41)

In order to make the information on the gender pay gap at organisational level widely available, Member States should entrust the monitoring body designated pursuant to this Directive to compile the data on the pay gap received from employers without putting an additional burden on the latter. The monitoring body should make those data public, including by publishing them on an easily accessible website, allowing comparison of the data of individual employers, sectors and regions of the Member State concerned.

(42)

Member States may acknowledge employers that are not subject to the reporting obligations set out in this Directive, which voluntarily report on their pay, for instance by means of a pay transparency label, with a view to promoting good practices in relation to the rights and obligations laid down in this Directive.

(43)

Joint pay assessments should trigger the review and revision of pay structures in organisations with at least 100 workers that show pay inequalities. The joint pay assessment should be carried out if employers and the workers’ representatives concerned do not agree that the difference in average pay level between female and male workers of at least 5 % in a given category of workers can be justified on the basis of objective, gender-neutral criteria, if such a justification is not provided by the employer, or if the employer has not remedied such a difference in pay level within six months of the date of submission of the pay reporting. The joint pay assessment should be carried out by employers in cooperation with workers’ representatives. If there are no workers’ representatives, they should be designated by workers for the purpose of the joint pay assessment. Joint pay assessments should lead, within a reasonable period of time, to the elimination of gender-based pay discrimination through the adoption of remedial measures.

(44)

Any processing or publication of information under this Directive should comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (14). Specific safeguards should be added to prevent the direct or indirect disclosure of information of an identifiable worker. Workers should not be prevented from voluntarily disclosing their pay for the purpose of the enforcement of the principle of equal pay.

(45)

It is important that the social partners discuss and pay particular attention to matters of equal pay in collective bargaining. The various features of national social dialogue and collective bargaining systems across the Union and the autonomy and contractual freedom of the social partners, as well as their capacity as representatives of workers and employers should be respected. Therefore, Member States, in accordance with their national system and practices, should take appropriate measures to encourage the social partners to pay due attention to equal pay matters, which may include discussions at the appropriate level of collective bargaining, measures to stimulate and remove undue restrictions on the exercise of the right to collective bargaining related to the matters concerned and the development of gender-neutral job evaluation and classification systems.

(46)

All workers should have the necessary procedures at their disposal to facilitate the exercise of their right of access to justice. National legislation providing for the use of conciliation, or making the intervention of an equality body compulsory or subject to incentives or penalties should not prevent parties from exercising their right of access to the courts.

(47)

Involving equality bodies, in addition to other stakeholders, is instrumental in effectively applying the principle of equal pay. The powers and mandates of the national equality bodies should therefore be adequate to fully cover gender-based pay discrimination, including any pay transparency or any other rights and obligations laid down in this Directive. In order to overcome the procedural and cost-related obstacles faced by workers who seek to exercise their right to equal pay, equality bodies, as well as associations, organisations and workers’ representatives or other legal entities with an interest in ensuring equality between men and women should be able to represent individuals. They should be able to assist workers by acting on their behalf or in support of them, which would allow workers who have suffered discrimination to effectively institute a claim regarding the alleged infringement of their rights and the principle of equal pay.

(48)

Bringing claims on behalf or in support of several workers is a way to facilitate proceedings that would not otherwise have been brought because of procedural and financial barriers or a fear of victimisation. It is also facilitative when workers are facing discrimination on multiple grounds which can be difficult to disentangle. Collective claims have the potential to uncover systemic discrimination and create visibility of the right to equal pay and of gender equality in society as a whole. The possibility of collective redress could motivate pro-active compliance with pay transparency measures, creating peer pressure, increasing employers’ awareness and willingness to act preventively, and addressing the systemic nature of pay discrimination. Member States may decide to set qualification criteria for representatives of workers in court proceedings relating to equal pay claims, in order to ensure that such representatives are adequately qualified.

(49)

Member States should ensure the allocation of sufficient resources to equality bodies for the effective and adequate performance of their tasks related to pay discrimination based on sex. Where the tasks are allocated to more than one body, Member States should ensure that they are adequately coordinated. This includes, for instance, allocating amounts recovered as fines to the equality bodies for the purpose of effectively carrying out their functions in regard to the enforcement of the right to equal pay, including bringing pay discrimination claims or assisting and supporting victims in bringing such claims.

(50)

Compensation should cover in full the loss and damage sustained as a result of gender-based pay discrimination in accordance with the case-law of the Court of Justice (15). It should include full recovery of back pay and related bonuses or payments in kind, as well as compensation for lost opportunities, such as access to certain benefits depending on pay level, and for non-material damage, such as distress because of the undervaluation of work performed. Where appropriate, the compensation can take into account damage caused by pay discrimination based on sex that intersects with other protected grounds of discrimination. Member States should not fix a prior upper limit for such compensation.

(51)

In addition to compensation, other remedies should be provided for. Competent authorities or national courts should, for instance, be able to require an employer to take structural or organisational measures to comply with its obligations regarding equal pay. Such measures may include, for instance, an obligation to review the pay setting mechanism based on a gender-neutral evaluation and classification; to set up an action plan to eliminate the discrepancies discovered and to reduce any unjustified gaps in pay; to provide information and raise workers’ awareness of their right to equal pay; and to establish a mandatory training for human resources staff on equal pay and gender-neutral job evaluation and classification.

(52)

In accordance with the case- law of the Court of Justice (16), Directive 2006/54/EC establishes provisions to ensure that the burden of proof shifts to the respondent when there is a prima facie case of discrimination. Nevertheless, it is not always easy for victims and courts to know how to establish even that presumption. In case C-109/88, the Court of Justice held that when a system of pay is totally lacking in transparency, the burden of proof should be shifted to the respondent, irrespective of the worker showing a prima facie case of pay discrimination. Accordingly, the burden of proof should be shifted to the respondent where an employer does not comply with the pay transparency obligations set out in this Directive, for instance by refusing to provide information requested by the workers or not reporting on the gender pay gap, where relevant, save where the employer proves that such an infringement was manifestly unintentional and of a minor character.

(53)

In accordance with the case-law of the Court of Justice, national rules on limitation periods relating to the bringing of claims regarding alleged infringements of the rights provided for in this Directive should be such that they do not render virtually impossible or excessively difficult the exercise of those rights. Limitation periods create specific obstacles for victims of gender-based pay discrimination. For that purpose, common minimum standards should be established. Those standards should determine when the limitation period begins to run, the duration thereof and the circumstances under which it is suspended or interrupted, and should provide that the limitation period for bringing claims is at least three years. Limitation periods should not begin to run before the claimant is aware, or can reasonably be expected to be aware, of the infringement. Member States should be able to decide that the limitation period does not begin to run while the infringement is ongoing or before the end of the employment contract or employment relationship.

(54)

Litigation costs create a serious disincentive for victims of gender-based pay discrimination to bring claims regarding alleged infringements of their right to equal pay, leading to the insufficient protection of workers and the insufficient enforcement of the right to equal pay. In order to remove that significant procedural obstacle to justice, Member States should ensure that national courts can assess whether an unsuccessful claimant had reasonable grounds for bringing the claim and, if so, whether that claimant should not be required to pay the costs of the proceedings. This should in particular apply where a successful respondent has not complied with the pay transparency obligations set out in this Directive.

(55)

Member States should provide for effective, proportionate and dissuasive penalties in the event of infringements of national provisions adopted pursuant to this Directive or national provisions that are already in force on the date of entry into force of this Directive and that relate to the right to equal pay. Such penalties should include fines which could be based on the employer’s gross annual turnover or on the employer’s total payroll. Any other aggravating or mitigating factors that may apply in the circumstances of the case, for instance, where pay discrimination based on sex is combined with other protected grounds of discrimination should be taken into account. It is for the Member States to determine the infringements of the rights and obligations relating to equal pay for equal work or work of equal value for which fines are the most appropriate penalty.

(56)

Member States should establish specific penalties for repeated infringements of any right or obligation relating to equal pay between men and women for the same work or work of equal value, to reflect the severity of the infringement and to further deter such infringements. Such penalties could include different types of financial disincentives such as the revocation of public benefits or the exclusion, for a certain period of time, from any further award of financial inducements or from any public tender procedure.

(57)

Obligations on employers stemming from this Directive are part of the applicable obligations in the fields of environmental, social and labour law compliance with which Member States have to ensure under Directives 2014/23/EU (17), 2014/24/EU (18) and 2014/25/EU (19) of the European Parliament and of the Council in regard to participation in public procurement procedures. In order to comply with those obligations on employers as far as the right to equal pay is concerned, Member States should in particular ensure that economic operators, in the performance of a public contract or concession, have pay setting mechanisms that do not lead to a gender pay gap between workers in any category of workers performing equal work or work of equal value that cannot be justified on the basis of gender-neutral criteria. In addition, Member States should consider requiring contracting authorities to introduce, as appropriate, penalties and termination conditions ensuring compliance with the principle of equal pay in the performance of public contracts and concessions. Contracting authorities should also be able to take into account non-compliance with the principle of equal pay by the bidder or one of the bidder’s subcontractors when considering the application of exclusion grounds or when taking a decision not to award a contract to the tenderer submitting the most economically advantageous tender.

(58)

The effective implementation of the right to equal pay requires adequate administrative and court protection against any adverse treatment as a reaction to an attempt by workers to exercise that right, to any complaint to the employer or to any administrative procedure or court proceedings aiming to enforce compliance with that right. According to the case-law of the Court of Justice (20) the category of employees who are entitled to the protection should be interpreted broadly and include all employees who may be subject to retaliatory measures taken by an employer in response to a complaint of discrimination on grounds of sex. The protection is not limited solely to employees who have lodged complaints or their representatives, or to those who comply with certain formal requirements governing the recognition of a certain status, such as that of a witness.

(59)

In order to improve the enforcement of the principle of equal pay, this Directive should strengthen the existing enforcement tools and procedures in regard to the rights and obligations laid down in this Directive and the equal pay provisions set out in Directive 2006/54/EC.

(60)

This Directive lays down minimum requirements, thus respecting the Member States’ prerogative to introduce and maintain provisions that are more favourable to workers. Rights acquired under the existing legal framework should continue to apply, unless provisions that are more favourable to workers are introduced by this Directive. The implementation of this Directive cannot be used to reduce existing rights set out in existing Union or national law in this field, nor can it constitute valid grounds for reducing the rights of workers in regard to the principle of equal pay.

(61)

In order to ensure proper monitoring of the implementation of the right to equal pay, Member States should set up or designate a dedicated monitoring body. That body, which should be able to be part of an existing body pursuing similar objectives, should have specific tasks in relation to the implementation of the pay transparency measures provided for in this Directive and gather certain data to monitor pay inequalities and the impact of the pay transparency measures. Member States should be able to designate more than one body, provided that the monitoring and analysis functions set out in this Directive are ensured by a central body.

(62)

Compiling wage statistics broken down by sex and providing the Commission (Eurostat) with accurate and complete statistics is essential for analysing and monitoring changes in the gender pay gap at Union level. Council Regulation (EC) No 530/1999 (21) requires Member States to compile four-yearly structural earnings statistics at micro level, which provide harmonised data for the calculation of the gender pay gap. Annual high-quality statistics could increase transparency and enhance monitoring and awareness of gender pay inequality. The availability and comparability of such data is instrumental for assessing developments both at national level and throughout the Union. Relevant statistics transmitted to the Commission (Eurostat) should be collected for statistical purposes within the meaning of Regulation (EC) No 223/2009 of the European Parliament and of the Council (22).

(63)

Since the objectives of this Directive, namely a better and more effective application of the principle of equal pay through the establishment of common minimum requirements which should apply to all undertakings and organisations across the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of their 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. In accordance with the principle of proportionality as set out in that Article, this Directive, which limits itself to setting minimum standards, does not go beyond what is necessary in order to achieve those objectives.

(64)

The role of the social partners is of key importance in designing the way pay transparency measures are implemented in Member States, especially in those with high collective bargaining coverage. Member States should therefore have the possibility to entrust the social partners with the implementation of all or part of this Directive, provided that Member States take all the necessary steps to ensure that the results sought by this Directive are guaranteed at all times.

(65)

In implementing this Directive, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of micro, small or medium-sized enterprises. Member States should therefore assess the impact of their transposition measures on micro, small and medium-sized enterprises in order to ensure that those enterprises are not disproportionately affected, giving specific attention to microenterprises, to alleviate the administrative burden, and to publish the results of such assessments.

(66)

The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (23) and delivered an opinion on 27 April 2021,

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy’s application to register the name ‘Cedro di Santa Maria del Cedro’ 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 ‘Cedro di Santa Maria del Cedro’ should therefore be entered in the register,

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

On 7 October 2019, the company Medika Natura Sdn. Bhd. (‘the applicant’, initially Orchid Life Sdn Bhd) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place aqueous ethanolic extract of Labisia pumila on the Union market as a novel food. The applicant requested for aqueous ethanolic extract of Labisia pumila to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) intended for the adult population, excluding pregnant and lactating women, at the maximum use level of 750 mg per day.

(4)

On 7 October 2019, the applicant also made a request to the Commission for the protection of proprietary data, namely, pharmacokinetic study in rats (4), bacterial reverse mutation test (5), in vitro mammalian chromosome aberration test (6), mammalian erythrocyte micronucleus test in mice (7), repeated dose (90 days) oral toxicity study in rats (8), solubility test (9), in vitro micronucleus test (10) and one year chronic toxicity test (11).

(5)

On 14 April 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of aqueous ethanolic extract of Labisia pumila as a novel food.

(6)

On 28 September 2022, the Authority adopted its scientific opinion on the ‘Safety of an aqueous ethanolic extract of Labisia pumila as a novel food pursuant to Regulation (EU) 2015/2283’ (12) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that aqueous ethanolic extract (1:1) of the whole plant of Labisia pumila mixed with maltodextrin (2:1) which serves as a drying aid, is safe for the target population at levels of up to 350 mg per day. Therefore, that scientific opinion gives sufficient grounds to establish that aqueous ethanolic extract of Labisia pumila, when used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council intended for the adult population, excluding pregnant and lactating women, at the maximum use level of 350 mg per day, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the solubility test and toxicological information (studies on pharmacokinetics, genotoxicity, subchronic and chronic oral toxicity) without which it could not have assessed the novel food and reached its conclusion.

(9)

The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(10)

The applicant declared that it held proprietary and exclusive rights of reference to the pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test and one year chronic toxicity test at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(11)

The Commission assessed all the information provided by the applicant and considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test and one year chronic toxicity test should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place aqueous ethanolic extract of Labisia pumila on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)

However, restricting the authorisation of aqueous ethanolic extract of Labisia pumila and the reference to the data contained in the applicant’s file for its sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(13)

It is appropriate that the inclusion of aqueous ethanolic extract of Labisia pumila as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In this regard, in line with the conditions of use of food supplements containing aqueous ethanolic extract of Labisia pumila as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers by appropriate labelling that food supplements containing aqueous ethanolic extract of Labisia pumila should only be consumed by adults excluding pregnant and lactating women.

(14)

Aqueous ethanolic extract of Labisia pumila should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)

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

(1)

Regulation (EU) 2016/429 provides that consignments of animals, germinal products and products of animal origin must come from a third country or territory, or zone or compartment thereof, listed in accordance with Article 230(1) of that Regulation in order to enter the Union.

(2)

Commission Delegated Regulation (EU) 2020/692 (2) lays down the animal health requirements that consignments of certain species and categories of animals, germinal products and products of animal origin, from third countries or territories, or zones thereof, or compartments thereof in the case of aquaculture animals, must comply with in order to enter the Union.

(3)

Commission Implementing Regulation (EU) 2021/404 (3) establishes the lists of third countries, or territories, or zones or compartments thereof, from which the entry into the Union of the species and categories of animals, germinal products and products of animal origin falling within the scope of Delegated Regulation (EU) 2020/692 is permitted.

(4)

More particularly, Annexes V and XIV to Implementing Regulation (EU) 2021/404 set out the lists of third countries, or territories, or zones thereof authorised for the entry into the Union, respectively, of consignments of poultry, germinal products of poultry, and of fresh meat of poultry and game birds.

(5)

Canada has notified the Commission of two outbreaks of highly pathogenic avian influenza (HPAI) in poultry in the provinces of Ontario (1) and Quebec (1), which were confirmed on 17 April 2023 and 19 April 2023 by laboratory analysis (RT-PCR).

(6)

Furthermore, Chile has notified the Commission of three outbreaks of HPAI in poultry in the region of Valparaíso (2) and Biobío (1), which were confirmed between 18 April 2023 and 20 April 2023 by laboratory analysis (RT-PCR).

(7)

In addition, the United Kingdom has notified the Commission of six outbreaks of HPAI in poultry in the counties of Devon (1), South Yorkshire (1) Yorkshire (1) in England and Powys (3) in Wales, which were confirmed between 31 March 2023 and 29 April 2023 by laboratory analysis (RT-PCR).

(8)

Following those recent outbreaks of HPAI, the veterinary authorities of Canada, Chile and the United Kingdom established restricted zones of at least 10 km around the affected establishments and implemented a stamping-out policy in order to control the presence of HPAI and limit the spread of that disease.

(9)

Canada, Chile and the United Kingdom have submitted information to the Commission on the epidemiological situation on their territories and the measures they have taken to prevent the further spread of HPAI. That information has been evaluated by the Commission. On the basis of that evaluation and in order to protect the animal health status of the Union, the entry into the Union of consigments of poultry, germinal products of poultry, and fresh meat of poultry and game birds from the areas under restrictions established by the veterinary authorities of Canada, Chile and the United Kingdom due to the recent outbreaks of HPAI should no longer be authorised.

(10)

Furthermore, Canada has submitted updated information on the epidemiological situation on its territory in relation to eight outbreaks of HPAI in poultry establishments in the provinces of British Columbia (4), Ontario (3) and Quebec (1), which were confirmed between 5 April 2022 and 1 December 2022.

(11)

In addition, the United Kingdom has submitted updated information on the epidemiological situation on its territory in relation to 58 outbreaks of HPAI in poultry establishments in the counties of Cumbria (1), Herefordshire (1), Lincolnshire (6), Norfolk (42), North Yorkshire (1), Staffordshire (1) Suffolk (4), Worcestershire (1) and Yorkshire (1) in England, United Kingdom, which were confirmed between 3 September 2022 and 10 March 2023.

(12)

Furthermore, Canada and the United Kingdom have also submitted information on the measures they have taken to prevent the further spread of HPAI. In particular, following those outbreaks of that disease, Canada and the United Kingdom have implemented a stamping out policy in order to control and limit the spread of that disease, and they have also completed the requisite cleaning and disinfection following the implementation of the stamping out policy on the infected poultry establishments on their territories.

(13)

The Commission has evaluated the information submitted by Canada and the United Kingdom and concluded that the outbreaks of HPAI in poultry establishments have been cleared and that there is no longer a risk associated with the entry into the Union of poultry commodities from the zones of Canada and the United Kingdom from which the entry into the Union of poultry commodities was suspended following those outbreaks.

(14)

Annexes V and XIV to Implementing Regulation (EU) 2021/404 should be therefore amended to take account of the current epidemiological situation as regards HPAI in Canada, Chile and the United Kingdom.

(15)

Taking into account the current epidemiological situation in Canada, Chile and the United Kingdom as regards HPAI and the serious risk of its introduction into the Union, the amendments to be made to Annexes V and XIV to Implementing Regulation (EU) 2021/404 by this Regulation should take effect as a matter of urgency.

(16)

Commission Implementing Regulation (EU) 2023/868 (4) amended Annex V and Annex XIV to Implementing Regulation (EU) 2021/404 by amending in Annex V and in Annex XIV the rows for the zone US-2.278, by setting the opening date of this previously closed zone in the entries for the United States. As an error has been detected concerning the opening date of the zone US-2.278 in Annexes V and XIV, the rows for the zone US-2.278 in Annexes V and XIV should be corrected accordingly. This correction should apply from the date of application of Implementing Regulation (EU) 2023/868.

(17)

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