### without prejudice to the powers of the commission , the college or the executive board , the administrative director shall be independent in the performance of his or her duties and shall neither seek nor take instructions from any government or from any other body . ### without prejudice to the powers of the college or the executive board , the administrative director shall be independent in the performance of his or her duties and shall neither seek nor take instructions from any government or from any other body .


### preparing the programming document and submitting it to the executive board and college after consultation of the commission ; ### preparing the annual and multi - annual work programming and submitting it to the executive board for approval ;


### implementing the programming document and reporting to the executive board and college on its implementation ; ### implementing the annual and multi - annual work programming and reporting to the executive board and college on its implementation ;


### preparing an action plan following - up on the conclusions of the internal or external audit reports , evaluations and investigations , including those of the european data protection supervisor and olaf and reporting on progress twice a year to the executive board , the commission and the european data protection supervisor ; ### preparing an action plan following - up on the conclusions of the internal or external audit reports , evaluations and investigations , including those of the european data protection supervisor and olaf and reporting on progress twice a year to the executive board , the commission , the european parliament and the european data protection supervisor ;


### preparing an action plan following - up on the conclusions of the internal or external audit reports , evaluations and investigations , including those of the european data protection supervisor and olaf and reporting on progress twice a year to the executive board , the commission and the european data protection supervisor ; ### preparing an action plan following - up on the conclusions of the internal or external audit reports , evaluations and investigations , including those of the european data protection supervisor and olaf and reporting on progress twice a year to the college , the executive board , the commission and the european data protection supervisor ;


### maintaining close relations with the europol national unit . ### maintaining close relations with the europol national unit , other european judicial network contact points and other relevant competent national authorities .


### the competent authorities of the member states shall exchange with eurojust any information necessary for the performance of its tasks in accordance with articles 2 and 4 as well as with the rules on data protection set out in this regulation . this shall at least include the information referred to in paragraphs 5 , 6 and 7 . ### the competent authorities of the member states shall exchange with eurojust any information necessary for the performance of its tasks in accordance with articles 2 and 4 as well as with the rules on data protection set out in this regulation . this shall at least include the information referred to in paragraphs 4 , 5 and 6 .


### the transmission of information to eurojust shall be interpreted as a request for the assistance of eurojust in the case concerned only if so specified by a competent authority . ### the transmission of information to eurojust shall only be interpreted as a request for the assistance of eurojust in the case concerned if so specified by a competent authority .


### the national competent authorities shall inform their national members without undue delay of any case concerning crimes under the competence of eurojust affecting at least three member states and for which requests for or decisions on judicial cooperation , including those based on instruments giving effect to the principle of mutual recognition , have been transmitted to at least two member states . ### the national competent authorities shall inform their national members without undue delay of any case affecting at least three member states directly and for which requests for or decisions on judicial cooperation , including those based on instruments giving effect to the principle of mutual recognition , have been transmitted to at least two member states and , the offence involved is punishable in the requesting or issuing member state by a custodial sentence or a detention order for a maximum period of at least five or six years to be decided by the member state concerned , and is included in the following list : trafficking in human beings ; sexual abuse and sexual exploitation including child pornography and solicitation of children for sexual purposes ; drug trafficking ; illicit trafficking in firearms , their parts and components and ammunition and explosives ; corruption ; crime against the financial interests of the union ; forgery of money and means of payment money laundering activities ; computer crime ; or there are factual indications that a criminal organisation is involved ; or there are indications that the case may have a serious cross - border dimension or repercussions at union level or that it might affect member states other than those directly involved .


### information referred to in this article shall be provided in a structured way as established by eurojust . ### information referred to in this article shall be provided in a structured way as established by eurojust . the national authority shall not be obliged to provide this information when it has already been transmitted to eurojust in accordance with other provisions of this regulation .


### eurojust shall establish a case management system composed of temporary work files and of an index which contain personal data as referred to in annex 2 and non - personal data . ### eurojust shall establish a case management system including temporary work files and of an index which contain personal data as referred to in annex 2 and non - personal data .


### personal data processed by eurojust may not be stored beyond the first applicable among the following dates : ### operational personal data processed by eurojust shall be stored by eurojust as long as necessary and proportionate for the purpose for which the data are processed . the operational data may not be stored beyond the first applicable among the following dates :


### the national members concerned by the request shall deal with it and reach a decision on eurojust ' s behalf . the request shall be dealt with in full within three months of receipt . where the members are not in agreement , they shall refer the matter to the college , which shall take its decision on the request by a two - thirds majority . ### the provision of information in response to any request under paragraph 1 may be refused or restricted if such refusal or restriction constitutes a measure that is necessary in order to : enable eurojust to fulfil its tasks properly ; protect security and public order or prevent crime ; guarantee that any national investigation will not be jeopardised ; or protect the rights and freedoms of third parties . when the applicability of an exemption is assessed , the fundamental rights and interests of the data subject shall be taken into account .


### eurojust shall process personal data in such a way that that it can be established which authority provided the data or where the personal data has been retrieved from . ### eurojust shall process operational personal data in such a way that that it can be established which authority provided the data or where the personal data has been retrieved from .


### the responsibility for the quality of personal data shall lie with the member state which provided the personal data to eurojust and with eurojust for personal data provided by eu bodies , third countries or international organisations , as well for personal data retrieved by eurojust from publicly available sources . ### the responsibility for the quality of operational personal data shall lie with the member state which provided the personal data to eurojust and with eurojust for operational personal data provided by union bodies , third countries or international organisations , as well for operational personal data retrieved by eurojust from publicly available sources


### in so far as relevant to the performance of its tasks and subject to any restriction stipulated pursuant to article 21 , eurojust may directly exchange all information , with the exception of personal data , with the entities referred to in paragraph 1 . ### in so far as relevant to the performance of its tasks and subject to any restriction stipulated pursuant to article 21 and article 62 , eurojust may directly exchange all information , with the exception of personal data , with the entities referred to in paragraph 1 .


### personal data shall only be transferred by eurojust to third countries , international organisations , and interpol if this is necessary for preventing and combating crime that falls under eurojust ' s competence and in accordance with this regulation . if the data to be transferred have been provided by a member state , eurojust shall seek that member state ' s consent , unless : ### personal data shall only be transferred by eurojust union bodies , third countries , international organisations and interpol if this is necessary for preventing and combating crime that falls under eurojust ' s competence and in accordance with this regulation . if the data to be transferred have been provided by a member state , eurojust shall obtain the consent of the relevant competent authority in that member state , unless :


### the secretariat of the network for joint investigation teams and of the network set up by decision 2002 / 494 / jha shall form part of the staff of eurojust . these secretariats shall function as separate units . they may draw on the administrative resources of eurojust which are necessary for the performance of their tasks . coordination between the secretariats shall be ensured by eurojust . this paragraph shall apply to the secretariat of any new network set up by a decision of the council where that decision provides that the secretariat shall be provided by eurojust . ### the secretariat of the network for joint investigation teams and of the network set up by decision 2002 / 494 / jha shall form part of the staff of eurojust . these secretariats shall function as separate units . they may draw on the administrative resources of eurojust which are necessary for the performance of their tasks . coordination between the secretariats shall be ensured by eurojust . this paragraph shall apply to the secretariat of any relevant network involved in judicial cooperation in criminal matters for which support in the form of a secretariat is to be provided by eurojust . eurojust may support , including where appropriate by means of a secretariat hosted at eurojust , relevant european networks and bodies involved in judicial cooperation in criminal matters .


### if during eurojust ' s information processing activities in respect of an individual investigation , eurojust or a member state identifies the necessity for coordination , cooperation or support in accordance with the mandate of europol , eurojust shall notify them thereof and shall initiate the procedure for sharing the information , in accordance with the decision of the member state providing the information . in such a case eurojust shall consult with europol . ### if during eurojust ' s information processing activities in respect of an individual investigation , eurojust or a member state identifies the necessity for coordination , cooperation or support in accordance with the mandate of europol , eurojust shall notify them thereof and shall initiate the procedure for sharing the information , in accordance with the decision of the member state providing the information . in such a case europol shall consult with eurojust .


### eurojust shall establish and maintain a special relationship with the european public prosecutor ' s office based on close cooperation and the development of operational , administrative and management links between them as defined below . to this end , the european public prosecutor and the president of eurojust shall meet on a regular basis to discuss issues of common concern . ### eurojust shall establish and maintain a close relationship with the european public prosecutor ' s office based on mutual cooperation within their respective mandates and competences and on the development of operational and administrative links between them as defined in this article . to this end , the president of eurojust and the european chief prosecutor shall meet on a regular basis to discuss issues of common interest .


### eurojust shall treat any request for support emanating from the european public prosecutor ' s office without undue delay , and shall deal with such requests , where appropriate , as if they had been received from a national authority competent for judicial cooperation . ### eurojust shall treat requests for support emanating from the european public prosecutor ' s office without undue delay , and shall deal with such requests , where appropriate , as if they had been received from a national authority competent for judicial cooperation .


### for the purpose of identifying whether information available at eurojust matches with information processed by the european public prosecutor ' s office , eurojust shall put in place a mechanism for automatic cross - checking of data entered into its case management system . whenever a match is found between data entered into the case management system by the european public prosecutor ' s office and data entered by eurojust , the fact that there is a match will be communicated to both eurojust and the european public prosecutor ' s office , as well as the member state which provided the data to eurojust . in cases where the data was provided by a third party , eurojust shall only inform that third party of the match found with the consent of the european public prosecutor ' s office . ### eurojust shall have access on the basis of a hit / no - hit system to information in the case management system of the european public prosecutors office . whenever a match is found between data entered into the case management system by the european public prosecutor’s office and data held by eurojust , the fact that there is a match will be communicated to both eurojust and the european public prosecutor’s office , as well as the member states which provided the data to eurojust . eurojust shall take the appropriate measures to enable the european public prosecutor’s office to have access to information in its case management system on the basis of a hit / no - hit system .


### for purposes of the receipt and transmission of information between eurojust and olaf , and without prejudice to article 8 , member states shall ensure that the national members of eurojust shall be regarded as competent authorities of the member states solely for the purposes of regulation no 1073 / 1999 and council regulation no 1074 / 199919 . the exchange of information between olaf and national members shall be without prejudice to the information which must be given to other competent authorities under those regulations . __________________ 19 oj l 136 , 31 . 5 . 1999 , p . 8 . ### for purposes of the receipt and transmission of information between eurojust and olaf , and without prejudice to article 8 , member states shall ensure that the national members of eurojust shall be regarded as competent authorities of the member states solely for the purposes of regulation of the european parliament and of the council no 883 / 2013 concerning investigations conducted by the european anti - fraud office the exchange of information between olaf and national members shall be without prejudice to the information which must be given to other competent authorities under those regulations . __________________ 19 oj l 136 , 31 . 5 . 1999 , p . 8 .


### eurojust may establish working arrangements with the entities referred to in article 38 . ### eurojust may establish memoranda of understanding with the entities referred to in article 38 .


### liaison magistrates posted to third countries ### liaison magistrates posted to third countries and from third - countries to eurojust


### for the purpose of facilitating judicial cooperation with third countries in cases in which eurojust is providing assistance in accordance with this regulation , the college may post liaison magistrates to a third country subject to a working arrangement as referred to in article 43 with that third country . ### for the purpose of facilitating judicial cooperation with third countries in cases in which eurojust is providing assistance in accordance with this regulation , the college may post liaison magistrates to a third country subject to a working arrangement as referred to in article 43 with that third country . eurojust may establish working arrangements with entities referred to in article 38 which may include the secondment of liaison magistrates to eurojust .


### the expenditure of eurojust shall include staff remuneration , administrative and infrastructure expenses , operating costs . ### the expenditure of eurojust shall include staff remuneration , administrative and infrastructure expenses , operating costs , including funding for joint investigation teams .


### each year the administrative director shall draw up a draft statement of estimates of eurojust ' s revenue and expenditure together , for the following financial year , including the establishment plan , and send it to the college . ### each year the administrative director shall draw up a draft statement of estimates of eurojust ' s revenue and expenditure together , for the following financial year , including the establishment plan , and send it to the executive board . the european judicial network and other networks of the union involved in cooperation in criminal matters referred to in article 39 shall be involved on the parts related to their activities in due time before forwarding the estimate to the commission .


### the college shall , on the basis of that draft , produce a provisional draft estimate of eurojust ' s revenue and expenditure for the following financial year . ### the executive board shall , on the basis of that draft , prepare a provisional draft estimate of eurojust ' s revenue and expenditure for the following financial year which shall be forwarded to the college for adoption .


### for any building project likely to have significant implications for the budget eurojust shall inform the european parliament and the council as early as possible in accordance with the provisions of article 203 of regulation no 966 / 2012 . ### for any building project likely to have significant implications for eurojust ' s budget article 88 of delegated regulation 1271 / 2013 shall apply .


### on receipt of the court of auditors ' observations on eurojust ' s provisional accounts pursuant to article 148 of regulation no 966 / 2012 , the administrative director shall draw up eurojust ' s final accounts under his or her own responsibility and submit them to the college for an opinion . ### on receipt of the court of auditors ' observations on eurojust ' s provisional accounts pursuant to article 148 of regulation no 966 / 2012 , the administrative director shall draw up eurojust ' s final accounts under his or her own responsibility and submit them to the executive board for an opinion .


### the college shall deliver an opinion on eurojust ' s final accounts . ### the executive board shall deliver an opinion on eurojust ' s final accounts .


### the administrative director shall , by 1 july following each financial year , send the final accounts to the european parliament , the council , the commission and the court of auditors , together with the college ' s opinion . ### the administrative director shall , by 1 july following each financial year , send the final accounts to the european parliament , the council , the commission and the court of auditors , together with the executive board ' s opinion .


### the financial rules applicable to eurojust shall be adopted by the college in accordance with [ regulation 2343 / 2002 of 23 december 2002 on the framework financial regulation for the bodies referred to in article 185 of council regulation no 1605 / 2002 on the financial regulation applicable to the general budget of the european communities ] and after consultation with the commission . they shall not depart from [ regulation 2343 / 2002 ] unless such departure is specifically required for eurojust ' s operation and the commission has given its prior consent . ### the financial rules applicable to eurojust shall be adopted by the executive board in accordance with delegated regulation 1271 / 2013 of 30 september 2013 on the framework financial regulation for the bodies referred to in article 208 of regulation 966 / 2012 and after consultation with the commission . they shall not depart from regulation 1271 / 2013 unless such departure is specifically required for eurojust ' s operation and the commission has given its prior consent .


### the college shall adopt a decision laying down rules on the secondment to eurojust of national experts . ### the college shall adopt a decision laying down rules on the secondment to eurojust of national experts and on the use of other staff , notably to avoid potential conflicts of interest .


### the national members , their deputies and their assistants referred to in article 7 , eurojust staff , national correspondents and the data protection officer shall be bound by an obligation of confidentiality with respect to any information which has come to their knowledge in the course of the performance of their tasks . ### the national members , their deputies and their assistants referred to in article 7 , eurojust staff , national correspondents , seconded national experts , liaison magistrates , the data protection officer and members and staff of the european data protection supervisor shall be bound by an obligation of confidentiality with respect to any information which has come to their knowledge in the course of the performance of their tasks .


### the college shall , within six months of the date of its first meeting , adopt the detailed rules for applying regulation no 1049 / 2001 . ### the executive board shall , within six months of the date of its first meeting prepare the detailed rules for applying regulation no 1049 / 2001 for adoption by the college .


### the european court of auditors shall have the power of audit , on the basis of documents and on the spot , over all grant beneficiaries , contractors and subcontractors who have received union funds from eurojust . ### the european court of auditors shall regularly carry out audits on the compliance and on the performance of eurojust’s activities , on the basis of documents or on - the - spot checks , over all grant beneficiaries , contractors and subcontractors who have received union funds from eurojust .


### security rules on the protection of classified information ### security rules on the protection of sensitive non - classified and classified information


### eurojust shall apply the security principles contained in the commission ' s security rules for protecting european union classified information and sensitive non - classified information , as set out in the annex to commission decision 2001 / 844 / ec , ecsc , euratom23 . this shall cover , inter alia , provisions for the exchange , processing and storage of such information . __________________ 23 oj l 317 , 3 . 12 . 2001 , p . 1 . ### eurojust shall establish internal rules on the protection of the european union classified information which shall be consistent with council decision 2013 / 488 / eu in order to ensure an equivalent level of protection for such information __________________ 23 oj l 317 , 3 . 12 . 2001 , p . 1 .


### –terrorism ; ### –terrorism , terrorist offences , offences related to a terrorist group and offences related to terrorist activities :


### –money - laundering ; ### –money - laundering activities ;


### –murder , grievous bodily injury ; ### –murder and grievous bodily injury ;


### –environmental crime ; ### –environmental crime , including ship - source pollution ;


### directive 2001 / 82 / ec of the european parliament and of the council5 and regulation 726 / 2004 of the european parliament and of the council6 constituted the union regulatory framework for the manufacture , authorisation and distribution of veterinary medicinal products . in the light of the experience acquired and following the assessment by the commission of the functioning of the internal market for veterinary medicinal products , the regulatory framework for veterinary medicinal products has been reviewed , and regulation no [ &#8230 ; ] of the european parliament and of the council7 laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted . ___________ 5 directive 2001 / 82 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to veterinary medicinal products . 6 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 7 regulation … of the european parliament and of the council of … … … on veterinary medicinal products . ### directive 2001 / 82 / ec of the european parliament and of the council5 and regulation 726 / 2004 of the european parliament and of the council6 constituted the union regulatory framework for the manufacture , authorisation and distribution of veterinary medicinal products . in the light of the experience acquired and following the assessment by the commission of the functioning of the internal market for veterinary medicinal products , the regulatory framework for veterinary medicinal products has been reviewed , and regulation no [ &#8230 ; ] of the european parliament and of the council laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted , with a view to harmonisation of the laws of the member states . ___________ 5 directive 2001 / 82 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to veterinary medicinal products . 6 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 7 regulation … of the european parliament and of the council of … … … on veterinary medicinal products .


### as a consequence of the entry into force of the treaty of lisbon , the powers conferred on the commission under regulation no 726 / 2004 should be aligned to articles 290 and 291 of the treaty on the functioning of the european union . in order to supplement or amend certain non - essential elements of regulation no 726 / 2004 , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of amending the annex to technical and scientific progress , determining the situations in which post - authorisation efficacy studies may be required , laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations , establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this regulation , the maximum amounts of these penalties as well as the conditions and methods for their collection . ### as a consequence of the entry into force of the treaty of lisbon , the powers conferred on the commission under regulation no 726 / 2004 should be aligned to articles 290 and 291 of the treaty on the functioning of the european union . in order to supplement or amend certain non - essential elements of regulation no 726 / 2004 , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of amending the annex with regard to technical and scientific progress so as to facilitate the placing on the market of new medicinal products , determining the situations in which post - authorisation efficacy studies may be required , laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations , establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this regulation , the maximum amounts of these penalties as well as the conditions and methods for their collection .


### the provisions of this regulation shall not affect the powers of member states ' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health , economic and social conditions . in particular , member states shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies . ### in article 1 , the second paragraph is replaced by the following : ' the provisions of this regulation shall not affect the powers of member states ' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health , economic and social conditions , provided that member states take in due consideration the reference comparative efficacy and reference cost - effective evaluation of medicinal product as per the provisions stated in article 9 . in particular , member states shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies . '


### ʻthe definitions laid down in article 1 of directive 2001 / 83 / ec shall apply for the purposes of this regulationʼ . ### ʻthe definitions laid down in article 1 of directive 2001 / 83 / ec and in regulation 2015 / . . . shall apply for the purposes of this regulationʼ .


### the agency shall provide the member states and the institutions of the community with the best possible scientific advice on any question relating to the evaluation of the quality , safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of community legislation relating to medicinal products . ### in article 57 , subparagraph 1 is replaced by the following : ' 1 . the agency shall provide the member states and the institutions of the community with the best possible scientific advice on any question relating to the evaluation of the quality , safety , efficacy and cost effectiveness of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of community legislation relating to medicinal products . '


### ʻarticle 86 at least every ten years , the commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this regulation , and in chapter 4 of title iii of directive 2001 / 83 / ec . ʼ ; ### ̒article 86 at least every five years , the commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this regulation , in chapter 4 of title iii of directive 2001 / 83 / ec and in regulation 2015 / . . . . ʼ ;


### in order to guarantee the free movement of products within the union , it is necessary to ensure that products fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union market for goods can thrive . rules are therefore necessary to ensure this enforcement throughout the internal market , including on products entering the union from third countries . ### in order to guarantee the free movement of products within the union , it is necessary to ensure that products fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union market for goods can thrive . rules are therefore necessary to ensure this enforcement throughout the internal market , including on products entering the union from third countries . in order to facilitate compliance by economic actors with union law and to empower market surveillance authorities in their enforcement operations , those requirements should strike the right balance between simplicity , and effectiveness . the requirements of this regulation and their application are designed so as to prioritise surveillance of those products which might pose a serious risk .


### in order to guarantee the free movement of products within the union , it is necessary to ensure that products fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union market for goods can thrive . rules are therefore necessary to ensure this enforcement throughout the internal market , including on products entering the union from third countries . ### in order to guarantee the free movement of products within the union , it is necessary to ensure that products are fully compliant with the eu law and fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security , similarly to requirements governing similar products produced within the eu single market . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union market for goods can thrive . rules are therefore necessary to ensure this enforcement throughout the internal market , including on products entering the union from third countries .


### responsibility for enforcing union harmonisation legislation should lie with the member states , whose market surveillance authorities should be required to ensure that the legislation is fully complied with . the member states should , therefore , establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities . ### responsibility for enforcing union harmonisation legislation should lie with the member states , whose market surveillance authorities should be required to ensure that the legislation is fully complied with . the member states should , therefore , establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities , subject to the monitoring , by the commission , of the proper enforcement of union harmonisation legislation .


### responsibility for enforcing union harmonisation legislation should lie with the member states , whose market surveillance authorities should be required to ensure that the legislation is fully complied with . the member states should , therefore , establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities . ### responsibility for enforcing union harmonisation legislation should lie with the member states , whose market surveillance authorities should be required to ensure that the legislation is fully complied with . the member states should , therefore , establish harmonised systematic approaches , including effective , proportionate and dissuasive penalties , to ensure effectiveness of market surveillance and other enforcement activities . in case of serious and recurrent breaches of compliance should be followed by sanctions , corresponding to 5% of the turnover of an entity .


### market surveillance activities should be thorough and effective , to ensure that union harmonisation legislation on products is applied correctly . given that controls may represent a burden for economic operators , market surveillance authorities should organise and conduct inspection activities , taking their interests into account and limiting the said burden to what is necessary for the performance of efficient and effective controls . furthermore , market surveillance activities should be performed with the same level of care by the competent authorities of the member state irrespective of whether non - compliance of the given product is relevant on the territory of that member state or is likely to have an impact on the market of another member state . ### market surveillance activities should be thorough and effective , to ensure that union harmonisation legislation on products is applied correctly . given that controls may represent a burden for economic operators , market surveillance authorities should organise and conduct inspection activities taking the interests of those operators into account , and limiting the said burden to what is necessary for the performance of efficient and effective controls . furthermore , market surveillance activities should be performed with the same level of care by the competent authorities of the member state irrespective of whether non - compliance of the given product is relevant on the territory of that member state or is likely to have an impact on the market of another member state . uniform conditions for inspection activities carried out by the market surveillance authorities when a product presents a known or emerging risk should be laid down .


### to ensure the reliability and consistency of testing across the union in the market surveillance framework , the commission should designate union testing facilities . furthermore , a more comprehensive information system should be developed for sharing test results within the union in order to avoid unnecessary duplication and to ensure greater consistency at union level . ### to ensure the reliability and consistency of testing across the union in the market surveillance framework , the commission should designate union testing facilities . the market surveillance authorities should take full account of the results of tests carried out by those union testing facilities . furthermore , a more comprehensive information system should be developed for sharing test results within the union in order to avoid unnecessary duplication and to ensure greater consistency at union level . union testing facilities should act as knowledge centres in respect of known and emerging risks and also assist the union and member states to develop common state of the art testing methodologies .


### member states should be required to ensure that adequate financial resources are always available in order to staff and equip the market surveillance authorities appropriately . an efficient market surveillance activity is demanding in terms of resources , and stable resources should be provided , at a level appropriate to the enforcement needs at any given moment . public financing should therefore be supplemented by the collection of fees to cover the costs incurred when performing market surveillance activities in relation to products that were found to be non - compliant , and taking due account of the economic operator ' s compliance record . ### member states should be required to ensure that adequate financial resources are always available in order to staff and equip the market surveillance authorities appropriately . an efficient market surveillance activity is demanding in terms of resources , and stable resources should be provided , at a level appropriate to the enforcement needs at any given moment . administrative and automated checks cannot serve as a substitute to physical checks which guarantee the substantial compliance of a product with the relevant union legislation . public financing should therefore be supplemented by the collection of fees to cover the costs incurred when performing market surveillance activities in relation to products that were found to be non - compliant , and taking due account of the economic operator ' s compliance record .


### ‘ economic operator’ means the manufacturer , the authorised representative , the importer or the distributor , and including : ### ‘ economic operator’ means the manufacturer , the authorised representative , the importer or the distributor , the intermediaries or any other natural or legal person participating in the placing on the market of the products , and including :


### person responsible for compliance information ### economic operators responsible for compliance


### if the union harmonisation legislation applicable to the product provides for an eu declaration of conformity and technical documentation , keeping the declaration and technical documentation at the disposal of market surveillance authorities for the period required by that legislation ; ### if the union harmonisation legislation applicable to the product provides for an eu declaration of conformity and technical documentation , verifying that the eu declaration of conformity and technical documentation have been drawn up and keeping the declaration of conformity and technical documentation at the disposal of market surveillance authorities for at least 10 years , if not specified otherwise by that union harmonisation legislation . importers shall keep a copy of the declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities , upon request ;


### cooperating with the market surveillance authorities , at their request , on any action taken to eliminate or , if that is not possible , mitigate the risks posed by the product . ### cooperating with the market surveillance authorities and take immediate action to remedy the case of a product presenting a risk or the case of a product being non - compliant with the requirements set out in union harmonisation legislation or harmonised standards applicable to the product in question , at their own initiative or when required to do so by the market surveillance authorities ;


### the identity and contact details of the person responsible for compliance information with respect to the product shall be indicated on or identifiable from information indicated on the product , its packaging , the parcel or an accompanying document . ### the name , registered trade name or registered trademark and the contact details , including the postal address , and if available a website address of the person responsible for compliance with respect to the product shall be indicated on the product or where not possible because of the size or physical characteristics of the product on its packaging or the parcel or an accompanying documents . when the manufacturer , the importer or the authorised representative use a website address in addition to the other required information to identify the person responsible for compliance , this website address can be used instead of the physical address , as defined in articles r2 - 6 and r4 - 3 of decision 768 / 2008 / ec .


### compliance partnership arrangements ### cooperation between market surveillance authorities and economic operators


### a market surveillance authority may enter into a partnership arrangement with an economic operator established in its territory under which the authority agrees to provide the economic operator with advice and guidance in relation to the union harmonisation legislation applicable to the products for which the economic operator is responsible . ### a market surveillance authority may enter into a partnership arrangement with an economic operator established in its territory under which the authority agrees to provide the economic operator with advice and guidance in relation to the union harmonisation legislation applicable to the products for which the economic operator is responsible . these arrangements shall not preclude an independent and unbiased assessment through market surveillance authorities and shall not result in unfair competition between economic operators within the european union and within the european union and third countries .


### a market surveillance authority may enter into a partnership arrangement with an economic operator established in its territory under which the authority agrees to provide the economic operator with advice and guidance in relation to the union harmonisation legislation applicable to the products for which the economic operator is responsible . ### upon request , a market surveillance authority shall , where possible , taking into account available resources , provide economic operators established in its territory with advice and guidance in relation to the union harmonisation legislation to the products for which the economic operator is responsible .


### a market surveillance authority may enter into a partnership arrangement with an economic operator established in its territory under which the authority agrees to provide the economic operator with advice and guidance in relation to the union harmonisation legislation applicable to the products for which the economic operator is responsible . ### a market surveillance authority may enter into a partnership arrangement with organisations representing businesses under which the authority agrees to provide the economic operator with advice and guidance in relation to the union harmonisation legislation applicable to the products for which the economic operator is responsible .


### a market surveillance authority that enters into a partnership arrangement under paragraph 1 may charge the economic operator fees representing the costs reasonably incurred by the authority in the exercise of its functions under paragraphs 1 and 2 . ### a market surveillance authority that enters into a partnership arrangement under paragraph 1 may not subcontract its work as part of such an arrangement to a notified body or any other conformity assessment body designated pursuant to union harmonisation legislation .


### any exchange of information between market surveillance authorities and businesses or organisations referred to in paragraph 1 for the purposes of preparing or implementing a memorandum of understanding entered into by them under that paragraph shall be deemed not to infringe the requirements of professional secrecy . ### any exchange of information between market surveillance authorities , the commission or the eu product compliance board , and businesses or organisations referred to in paragraph 1 for the purposes of preparing or implementing a memorandum of understanding entered into by them under that paragraph shall be treated in accordance with the requirements of professional secrecy . any further use of that information shall be subject to the strictest guarantees of confidentiality and of professional and commercial secrecy .


### market surveillance authorities shall perform controls as part of their activities set out in paragraph 1 , on a risk - based approach , taking into account , as a minimum , the following factors : ### market surveillance authorities shall prioritise actions for the largest risk - reduction opportunities and act in accordance with the principle of proportionality ; they shall perform controls as part of their activities set out in paragraph 1 , on a risk - based approach , taking into account , as a minimum , the following factors :


### market surveillance authorities shall perform controls as part of their activities set out in paragraph 1 , on a risk - based approach , taking into account , as a minimum , the following factors : ### market surveillance authorities shall perform controls as part of their activities set out in paragraph 1 , on a risk - based approach , prioritise actions for the largest risk - reduction and take into account , as a minimum , the following factors :


### each member state shall draw up a national market surveillance strategy , as a minimum , every 3 years . the strategy shall promote a consistent , comprehensive and integrated approach to market surveillance and enforcement of union harmonisation legislation within the territory of the member state and shall include all sectors and stages of the product supply chain , including imports and digital supply chains . ### each member state shall draw up a national market surveillance strategy , as a minimum , every 4 years , in view of the rapid market evolutions and new emerging risks . the strategy shall promote a consistent , comprehensive and integrated approach to market surveillance and enforcement of union harmonisation legislation within the territory of the member state and shall include all sectors and stages of the product supply chain , including imports and digital supply chains . in establishing their national market surveillance strategies , the member states shall consult stakeholders and make their comments available to the general public .


### an assessment of the occurrence of non - compliant products , in particular taking into account the risk - based controls referred to in articles 12 and 26 , and market trends that may affect non - compliance rates in the categories of product ; ### available information on the presence and / or occurrence of non - compliant products , in particular taking into account the risk - based controls referred to in articles 12 and 26 , and market trends provided by the commission that may affect non - compliance rates in the categories of product ;


### the enforcement actions planned in order to reduce the occurrence of non - compliance in those areas identified as a priority , including , where relevant , the minimum control levels envisaged for categories of product which have significant levels of non - compliance ; ### the enforcement actions planned in order to reduce the occurrence of non - compliance in those areas identified as a priority , including , where relevant , the minimum control levels envisaged for categories of product which have significant levels of non - compliance and which might pose a serious risk ;


### member states shall communicate their national market surveillance strategy through the system referred to under article 34 . ### member states shall communicate their national market surveillance strategy through the system referred to under article 34 . the commission shall define by means of implementing acts which data will be made public .


### member states shall communicate their national market surveillance strategy through the system referred to under article 34 . ### member states shall communicate their national market surveillance strategy through the system referred to under article 34 , and shall make it available to the general public .


### to request any representative or member of staff of the economic operator to give explanations of facts , information or documents relating to the subject - matter of the inspection and to record their answers ; ### to request a person authorised to represent the economic operator to give explanations of facts , information or documents relating to the subject - matter of the inspection and to record his answers ;


### market surveillance authorities shall publish any commitments given to them by economic operators , details of any corrective action taken by economic operators in their territory , and details of any temporary measures taken by the relevant market surveillance authority pursuant to this regulation . ### market surveillance authorities shall publish any commitments given to them by economic operators , details of any corrective action taken by economic operators in their territory , and details of any temporary measures taken by the relevant market surveillance authority pursuant to this regulation . market surveillance authorities shall ensure that this information is regularly updated and that the economic operator shall be given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public , prior to its publication or release .


### market surveillance authorities shall publish any commitments given to them by economic operators , details of any corrective action taken by economic operators in their territory , and details of any temporary measures taken by the relevant market surveillance authority pursuant to this regulation . ### market surveillance authorities shall publish , when they deem it relevant for the general public , any commitments given to them by economic operators , details of any corrective action taken by economic operators in their territory , and details of any temporary measures taken by the relevant market surveillance authority pursuant to this regulation .


### in deciding what checks to perform and on what scale , market surveillance authorities shall take into account , in particular , established principles of risk assessment and complaints . ### in order for the scope of market surveillance activities to be aligned across the union , member states shall use a sampling rate of 0 . 5 samples per 1 . 000 inhabitants per year as a minimum value . in determining actual sampling rates , market surveillance authorities shall take into account principles of risk of the product type , its intended uses and historical complaints for similar products . checks to be performed on the sample should be determined by consideration of these same criteria .


### where economic operators present test reports or certificates attesting conformity of their products with union harmonisation legislation issued by an accredited conformity assessment body , market surveillance authorities shall take due account of such reports or certificates . ### where economic operators present test reports or certificates attesting conformity of their products with union harmonisation legislation issued by an accredited conformity assessment body or any eu or non - eu laboratory accredited according to regulation no 765 / 2008 , market surveillance authorities shall take due account of such reports or certificates .


### where the market surveillance authorities of one member state decide to withdraw a product manufactured in another member state , they shall inform the economic operator concerned without delay . ### where the market surveillance authorities of one member state decide to withdraw a product manufactured in another member state or placed on the market in another member state , they shall inform the economic operator concerned without delay .


### before a measure , decision or order referred to in paragraph 1 is taken or made , the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 days , unless it is not possible to give him that opportunity because of the urgency of the measure , decision or order , based on health or safety requirements or other grounds relating to the public interests covered by the relevant union harmonisation legislation . ### before a measure , decision or order referred to in paragraph 1 is taken or made , the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days , unless it is not possible to give him that opportunity because of the urgency of the measure , decision or order , based on health or safety requirements or other grounds relating to the public interests covered by the relevant union harmonisation legislation .


### market surveillance authorities shall take measures to recall or withdraw products which present a serious risk or to prohibit the making available of them on the market . they shall inform the commission of such measures without delay , in accordance with article 19 . ### market surveillance authorities shall take measures to recall or withdraw products which present a serious risk to consumers , environment or the persons involved in the manufacturing of the product , or to prohibit the making available of such products on the market . they shall inform the commission of such measures without delay , in accordance with article 19 .


### the commission may designate union testing facilities for specific products or a specific category or group of products or for specific risks related to a category or group of products which are made available on the market . ### the commission may designate , after the consultation with the european market surveillance forum board referred to in article 32 , union testing facilities for specific products or a specific category or group of products or for specific risks related to a category or group of products which are made available on the market .


### market surveillance authorities may charge economic operators administrative fees in relation to instances of non - compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non - compliance . those costs may include the costs of carrying out testing for the purposes of a risk assessment , the costs of taking measures in accordance with article 30 and and the costs of their activities relating to products that are found to be non - compliant and subject to corrective action prior to their release for free circulation . ### market surveillance authorities may charge economic operators administrative fees in relation to instances of non - compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non - compliance . those costs shall be proportionate in relation to the non - compliance and may include the costs of carrying out testing for the purposes of a risk assessment , the costs of taking measures in accordance with article 30 and , the costs and time taken by the staff of market surveillance authorities to perform the market surveillance controls and the costs of their activities relating to products that are found to be non - compliant and subject to corrective action prior to their release for free circulation . costs of carrying out testing and / or risk assessment may only be charged in case the product itself is non - compliant or the manufacturer did not respond duly in reasonable time to requests by the market surveillance authority to correct non - compliances related to the ce mark , declaration of conformity or other informational legal requirements related to compliance .


### market surveillance authorities may charge economic operators administrative fees in relation to instances of non - compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non - compliance . those costs may include the costs of carrying out testing for the purposes of a risk assessment , the costs of taking measures in accordance with article 30 and and the costs of their activities relating to products that are found to be non - compliant and subject to corrective action prior to their release for free circulation . ### market surveillance authorities may charge economic operators administrative fees in relation to instances of non - compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non - compliance . those costs shall be proportionate in relation to the non - compliance . the costs may include the costs of carrying out testing for the purposes of a risk assessment , the costs of taking measures in accordance with article 30 and and the costs of their activities relating to products that are found to be non - compliant and subject to corrective action prior to their release for free circulation .


### the requested authority shall undertake appropriate investigations or take any other measures that are appropriate in order to gather the required information . where necessary , those investigations shall be carried out with the assistance of other market surveillance authorities . ### on receipt of a duly motivated request from an applicant authority , the requested authority shall give assistance on an adequate scale by gathering and supplying the necessary information or documentation , by carrying out appropriate investigations or any other appropriate measures , by assessing the conformity of the product , by determining the appropriate corrective measures and by participating in investigations initiated by the applicant authority .


### the applicant authority shall provide sufficient information , in the case of requests for mutual assistance under article 22 or 23 , to enable the requested authority to fulfill the request , including any necessary evidence obtainable only in the member state of the applicant authority . ### the applicant authority shall carry out itself all investigations reasonably possible before launching a request for assistance . the applicant authority shall provide all information available to enable the requested authority to fulfil the request , including any necessary evidence obtainable only in the member state of the applicant authority .


### requests for mutual assistance under article 22 or 23 shall be sent by the applicant authority to the single liaison office of the member state of the requested authority and also to the single liaison office of the member state of the applicant authority for information purposes . the single liaison office of the member state of the requested authority shall pass the requests on to the appropriate competent authority , without undue delay . ### requests for mutual assistance shall be transmitted directly to the requested authority .


### the characteristics of any product found to be non - compliant . ### the types of products found to be non - compliant .


### the commission shall draw up a report each year by 30 june , containing the information submitted by the member states for the previous calendar year . the report shall be published in the system referred to in article 34 . ### the commission shall draw up a report and a summary of the report each year by 30 june , containing the information submitted by the member states for the previous calendar year . the report shall be published in the system referred to in article 34 .


### where the commission becomes aware of a serious risk posed in a member state by products subject to union harmonisation legislation that are imported from a third country , it shall recommend to the member state concerned that it takes appropriate market surveillance measures . ### where the commission becomes aware of a serious risk posed in a member state by products subject to union harmonisation legislation that are imported from a third country , it shall request the member state concerned that it takes appropriate market surveillance measures .


### the network shall be composed of a union product compliance board , administrative coordination groups and a secretariat . ### the forum shall be composed of a european market surveillance forum board , administrative coordination groups and a secretariat .


### the commission shall develop and maintain an information and communication system for the collection and storage of information , in a structured form , on issues relating to the enforcement of union harmonisation legislation . the commission , single liaison offices , and authorities designated in accordance with article 26 shall have access to that system . ### the commission shall develop and maintain an information and communication system for the collection , processing and storage of information , in a structured form , on issues relating to the enforcement of union harmonisation legislation . the aim is to enable sharing of relevant data between member states and to allow the commission to monitor market surveillance activities . the commission , single liaison offices , market surveillance authorities and authorities designated in accordance with article 26 shall have access to that system . the information and communication system shall be linked through a common interface to the existing electronic system of the customs administration , based on regulation no 952 / 2013 of the european parliament and of the council laying down the union customs code as well as to the community rapid information system rapex , based on directive 2001 / 95 / ec of the european parliament and of the council on general product safety .


### the commission shall withdraw an approval granted under paragraph 3 where it is revealed that the products entering the union market do not comply with union harmonisation legislation in a significant number of instances . ### the commission , following approval of the emsf board , shall withdraw an approval granted under paragraph 3 where it is revealed that the products entering the union market do not comply with union harmonisation legislation in a significant number of instances . the commission shall immediately inform member states and the affected third country .


### applicability of regulation 765 / 2008 and amendments to union harmonisation legislation ### amendments to regulation 765 / 2008


### globalisation and technological change is likely to further increase the interconnectedness and interdependence of world economies . labour reallocation is an integral and inevitable part of such economic change . if the benefits of change are to be distributed fairly , offering assistance to displaced workers and those threatened by displacement is of utmost importance . the ‘ eu quality framework for anticipation of change and restructuring’22 , is the union policy instrument that sets the framework of best practice for anticipating and dealing with corporate restructuring . it offers a comprehensive framework on how the challenges of economic adjustment and restructuring and their employment and social impact should be addressed by adequate policy means . it also calls upon member states to use eu and national funding in a way to ensure that the social impact of restructuring , especially the adverse effects on employment , can be cushioned more effectively . the main union instruments to assist workers affected are the european social fund plus , which is designed to offer assistance in an anticipatory way , and the egf , which is designed to offer assistance in the case of unexpected major restructuring events in a reactive manner . _________________ 22 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions eu quality framework for anticipation of change and restructuring , 882 final , 13 . 12 . 2013 ) . ### globalisation and technological change is likely to further increase the interconnectedness and interdependence of world economies . labour reallocation is an integral and inevitable part of such economic change . if the benefits of change are to be distributed fairly , offering assistance to displaced workers and those threatened by displacement is of utmost importance . the ‘ eu quality framework for anticipation of change and restructuring 22 , is the union policy instrument that sets the framework of best practice for anticipating and dealing with corporate restructuring . it offers a comprehensive framework on how the challenges of economic adjustment and restructuring and their employment and social impact should be addressed by adequate policy means . it also calls upon member states to use eu and national funding in a way to ensure that the social impact of restructuring , especially the adverse effects on employment and the impact on the regions in question can be cushioned more effectively . the main union instruments to assist workers affected are the european social fund plus , which is designed to offer assistance in an anticipatory way , and the egf , which is designed to offer assistance in the case of unexpected major restructuring events in a reactive manner .


### the commission underlines the continuing importance of the role of the egf as a flexible fund to support workers who lose their jobs in large - scale restructuring events and to help them to find another job as rapidly as possible . the union should continue to provide specific , one - off support to facilitate the re - integration into employment of displaced workers in areas , sectors , territories or labour markets suffering a shock of serious economic disruption . considering the interplay and mutual effects of open trade , technological change or other factors like the transition to a low carbon economy , and therefore considering that it is increasingly difficult to single out a specific factor that causes job displacements , the mobilisation of the egf shall in the future only be based on the significant impact of a restructuring event . given its purpose , which is to provide support in situations of urgency and unexpected circumstances , complementing the more anticipatory assistance offered by the esf + , the egf shall remain a flexible and special instrument outside the budgetary ceilings of the multiannual financial framework , as set out in the commission ' s communication . ' a modern budget for a union that protects , empowers and defends - the multiannual financial framework for 2021 – 2027 ' and its annex27 . _________________ 27 commission swd 171 final and its annex com 321 final . ### the commission underlines the continuing importance of the role of the egf as a flexible fund to support workers who lose their jobs in large - scale restructuring events and to help them to find another job as rapidly as possible . the union should continue to provide specific , one - off support to facilitate the re - integration into employment of displaced workers in areas , sectors , territories or labour markets suffering a shock of serious economic disruption . considering the interplay and mutual effects of open trade , technological change or other factors like the planned transition to a low carbon economy , particularly in regions affected by the phasing - out of coal , and therefore considering that it is increasingly difficult to single out a specific factor that causes job displacements , the mobilisation of the egf shall in the future only be based on the significant impact of a restructuring event . given its purpose , which is to provide support in situations of urgency , complementing the more anticipatory assistance offered by the esf + , the egf shall remain a flexible and special instrument outside the budgetary ceilings of the multiannual financial framework , as set out in the commission ' s communication . ' a modern budget for a union that protects , empowers and defends - the multiannual financial framework for 2021 – 2027 ' and its annex27 . _________________ 27 commission swd 171 final and its annex com 321 final .


### as stated , in order to maintain the european nature of the egf , an application for support should be triggered when a major restructuring event causes a significant impact on the local or regional economy . such an impact should be defined by a minimum number of job displacements within a specific reference period . taking into account the findings of the mid - term evaluation , the threshold shall be set at 250 jobs displacement within a reference period of four months . taking into account that waves of dismissals in different sectors but the same region have an equally significant impact on the local labour market , regional applications shall be possible as well . in small labour markets , such as small member states or remote regions , including the outermost regions as referred in article 349 of the tfeu , or in exceptional circumstances , applications could be submitted in case of a lower number of job displacements . ### as stated , in order to maintain the european nature of the egf , an application for support should be triggered when a major restructuring event causes a significant impact on the local or regional economy . such an impact should be defined by a minimum number of job displacements within a specific reference period . taking into account the findings of the mid - term evaluation , the threshold shall be set at 250 jobs displacement within a reference period of four months . taking into account that waves of dismissals in different sectors but the same region or in neighbouring or cross - border regions have an equally significant impact on the local labour market , regional applications shall be possible as well . in small labour markets , such as small member states or remote regions , including the outermost regions as referred in article 349 of the tfeu , or in exceptional circumstances , applications could be submitted in case of a lower number of job displacements .


### financial contributions from the egf should be primarily directed at active labour market measures aimed at reintegrating beneficiaries rapidly into sustainable employment , either within or outside their initial sector of activity . measures should reflect the prospected needs of the local or regional labour market . however , whenever relevant , the mobility of displaced workers should also be supported in order to help find new employment elsewhere . a particular focus shall be laid on the dissemination of skills required in the digital age . the inclusion of pecuniary allowances in a coordinated package of personalised services should be restricted . companies could be encouraged to participate in the national co - funding for the egf - supported measures . ### financial contributions from the egf should be primarily directed at active labour market measures aimed at reintegrating beneficiaries rapidly into sustainable employment , either within or outside their initial sector of activity . measures should reflect the prospected needs of the local or regional labour market . however , whenever relevant , the mobility of displaced workers should also be supported in order to help find new employment elsewhere or in other regions . a particular focus shall be laid on the dissemination of skills required in the digital age and on access to digital technology . the inclusion of pecuniary allowances in a coordinated package of personalised services should be restricted . companies could be encouraged to participate in the national co - funding for the egf - supported measures .


### member states should pay particular attention to disadvantaged beneficiaries , including young and older unemployed persons and those at risk of poverty , when designing the coordinated package of active labour market policy measures , given that those groups experience particular problems in re - entering the labour market . notwithstanding , the principles of gender equality and of non - discrimination , which are among the union’s core values and are enshrined in the european pillar of social rights , should be respected and promoted when implementing the egf . ### member states should pay particular attention to disadvantaged beneficiaries , including young and older unemployed persons , the low - skilled and those at risk of poverty , when designing the coordinated package of active labour market policy measures , given that those groups experience particular problems in re - entering the labour market . notwithstanding , the principles of gender equality and of non - discrimination , which are among the union’s core values and are enshrined in the european pillar of social rights , should be respected and promoted when implementing the egf .


### in order to support beneficiaries effectively and rapidly , member states should do their utmost to submit complete applications for a financial contribution from the egf . in case the commission requires further information for the assessment of an application , the provision of additional information should be limited in time . ### in order to support beneficiaries effectively and rapidly , member states should do their utmost to submit as a matter of urgency complete applications for a financial contribution from the egf . in case the commission requires further information for the assessment of an application , the provision of additional information should be limited in time .


### special provisions should be included for information and communication activities on egf cases and outcomes . ### special provisions should be included for information and communication activities on egf cases and outcomes . reports on each egf case should be made available and should be standardised in terms of measures undertaken and outcomes . this would have the additional advantage of making cases comparable that member states can share good practices .


### in the interest of the beneficiaries , assistance should be made available as quickly and efficiently as possible . the member states and the union institutions involved in the egf decision - making process should do their utmost to reduce processing time and simplify procedures so as to ensure the smooth and rapid adoption of decisions on the mobilisation of the egf . therefore , the budgetary authority shall in the future decide on transfer requests submitted by the commission , not requiring a commission proposal for the mobilisation of the egf anymore . ### in the interest of the beneficiaries , assistance should be made available as quickly and efficiently as possible . the member states and the union institutions involved in the egf decision - making process should do their utmost to reduce processing time and simplify and adapt procedures to specific needs so as to ensure the smooth and rapid adoption of decisions on the mobilisation of the egf . therefore , the budgetary authority shall in the future decide on transfer requests submitted by the commission , not requiring a commission proposal for the mobilisation of the egf anymore .


### the cessation of activity of more than 250 displaced workers or self - employed persons , over a reference period of four months , in an enterprise in a member state , including where that cessation applies in its suppliers or downstream producers ; ### the cessation of activity of more than 250 displaced workers or self - employed persons , over a reference period of four months , in an enterprise in a member state or cross - border regions of neighbouring member states , including where that cessation applies in its suppliers or downstream producers ;


### the cessation of activity of more than 250 displaced workers or self - employed persons , over a reference period of six months , particularly in smes , where all operate in the same economic sector defined at nace revision 2 division level and located in one region or two contiguous regions defined at nuts 2 level or in more than two contiguous regions defined at nuts 2 level provided that there are more than 250 workers or self - employed persons affected in two of the regions combined ; ### the cessation of activity of more than 150 displaced workers or self - employed persons , over a reference period of six months , particularly in smes , where all operate in the same economic sector defined at nace revision 2 division level or located in one region or two contiguous regions defined at nuts 2 level or in more than two contiguous regions defined at nuts 2 level provided that there are more than 150 workers or self - employed persons affected in two of the regions combined ;


### the cessation of activity of more than 250 displaced workers or self - employed persons , over a reference period of four months , particularly in smes , operating in the same or different economic sectors defined at nace revision 2 division level and located in the same region defined at nuts 2 level . ### the cessation of activity of more than 150 displaced workers or self - employed persons , over a reference period of six months , particularly in smes , operating in the same or different economic sectors defined at nace revision 2 division level and located in the same region defined at nuts 2 level .


### in small labour markets or in exceptional circumstances , in particular with regard to applications involving smes , where duly substantiated by the applicant member state , an application for a financial contribution under this article may be considered admissible even if the criteria laid down in points , or of paragraph 1 are not entirely met , when the redundancies have a serious impact on employment and the local or regional economy . the applicant member state shall specify which of the intervention criteria set out in points , or of paragraph 1 are not entirely met . the aggregated amount of contributions in exceptional circumstances may not exceed 15 % of the annual ceiling of the egf . ### in small labour markets or in exceptional circumstances , in particular with regard to applications involving smes , where duly substantiated by the applicant member state , an application for a financial contribution under this article may be considered admissible even if the criteria laid down in points , or of paragraph 2 are not entirely met , when the redundancies have a serious impact on employment and the local or regional economy . the applicant member state shall specify which of the intervention criteria set out in points , or of paragraph 2 are not entirely met . the aggregated amount of contributions in exceptional circumstances may not exceed 15 % of the annual ceiling of the egf .


### special time - limited measures , such as job - search allowances , employers’ recruitment incentives , mobility allowances , training or subsistence allowances , including allowances for carers . ### special time - limited measures , such as job - search allowances , employers’ recruitment incentives , mobility and meal allowances , training or subsistence allowances , including allowances for carers . these actions are conditional on the active participation of the targeted beneficiaries in job - search or training activities .


### on the basis of the information provided by the member state , the commission shall complete its assessment of the application’s compliance with the conditions for providing a financial contribution , within 60 working days of the receipt of the complete application or , where applicable , of the translation of the application . where the commission is unable , exceptionally , to comply with that deadline , it shall provide a written explanation setting out the reasons for the delay . ### on the basis of the information provided by the member state , the commission shall complete its assessment of the application’s compliance with the conditions for providing a financial contribution , within 40 working days of the receipt of the complete application or , where applicable , of the translation of the application . where the commission is unable , exceptionally , to comply with that deadline , it shall provide a written explanation setting out the reasons for the delay and comply within a 20 - day extension of that deadline .


### a detailed description of the coordinated package of personalised services and related expenditure , including , in particular , any measures in support of employment initiatives for disadvantaged , older and young beneficiaries ; ### a detailed description of the coordinated package of personalised services and related expenditure , including , in particular , any measures in support of employment initiatives for disadvantaged , older and young beneficiaries and those from disadvantaged areas ;


### a detailed description of the coordinated package of personalised services and related expenditure , including , in particular , any measures in support of employment initiatives for disadvantaged , older and young beneficiaries ; ### a detailed description of the coordinated package of personalised services and related expenditure , including , in particular , any measures in support of employment initiatives for disadvantaged , low - skilled , older and young beneficiaries ;


### the commission shall maintain and update regularly an online presence , accessible in all official languages of the institutions of the union , to provide updated information on the egf , guidance on the submission of applications , as well as information on accepted and rejected applications and on the role of the european parliament and the council in the budgetary procedure . ### the commission shall maintain and update regularly an online presence , accessible in all official languages of the institutions of the union , to provide updated information on the egf , guidance on the submission of applications , as well as information on accepted and rejected applications accompanied by justification and on the role of the european parliament and the council in the budgetary procedure .


### by 1 august 2021 and every two years thereafter , the commission shall present to the european parliament and to the council a comprehensive , quantitative and qualitative report on the activities under this regulation and regulation no 1309 / 2013 in the previous two years . the report shall focus mainly on the results achieved by the egf and shall in particular contain information relating to applications submitted , decisions adopted , measures funded , including statistics on the indicators set out in the annex , and the complementarity of such measures with measures funded by other union funds , in particular esf + , and information relating to the winding - up of financial contributions made and shall also document those applications that have been rejected or reduced owing to a lack of sufficient appropriations or to non - eligibility . ### by 1 august 2021 and every two years thereafter , the commission shall present to the european parliament and to the council a comprehensive , quantitative and qualitative report on the activities under this regulation and regulation no 1309 / 2013 in the previous two years . the report shall focus mainly on the results achieved by the egf and shall in particular contain information relating to applications submitted , speed of their processing and potential deficiencies in existing rules , &#160 ; decisions adopted , measures funded , including statistics on the indicators set out in the annex , and the complementarity of such measures with measures funded by other union funds , in particular esf + , and information relating to the winding - up of financial contributions made and shall also document those applications that have been rejected or reduced owing to a lack of sufficient appropriations or to non - eligibility .


### the report shall be transmitted for information to the court of auditors , the european economic and social committee , the committee of the regions and the social partners . ### the report shall be transmitted for information to the member states , the court of auditors , the european economic and social committee , the committee of the regions and the social partners .


### principle 10 of the european pillar of social rights43 , proclaimed at gothenburg on 17 november 2017 , provides that every worker has the right to healthy , safe and well - adapted work environment . the right to a high level of protection of the health and safety at work , as well as to a working environment adapted to the professional needs of workers and which enables them to prolong their participation in the labour market includes also protection from carcinogens and mutagens at the workplace . __________________ 43 european pillar of social rights , november 2017 , https : / / ec . europa . eu / commission / priorities / deeper - and - fairer - economic - and - monetary - union / european - pillar - social - rights_en ### principle 10 of the european pillar of social rights43 , proclaimed at gothenburg on 17 november 2017 , provides that every worker has the right to healthy , safe and well - adapted work environment . the right to a high level of protection of the health and safety at work , as well as to a working environment adapted to the professional needs of workers includes also protection from carcinogens and mutagens at the workplace . __________________ 43 european pillar of social rights , november 2017 , https : / / ec . europa . eu / commission / priorities / deeper - and - fairer - economic - and - monetary - union / european - pillar - social - rights_en


### principle 10 of the european pillar of social rights43 , proclaimed at gothenburg on 17 november 2017 , provides that every worker has the right to healthy , safe and well - adapted work environment . the right to a high level of protection of the health and safety at work , as well as to a working environment adapted to the professional needs of workers and which enables them to prolong their participation in the labour market includes also protection from carcinogens and mutagens at the workplace . __________________ 43 european pillar of social rights , november 2017 , https : / / ec . europa . eu / commission / priorities / deeper - and - fairer - economic - and - monetary - union / european - pillar - social - rights_en ### one of the top social policy objectives of the european union is to avoid social fragmentation and social dumping in europe through renewed convergence towards better living and working conditions in the union . it is also one of the objectives of the european pillar of social rights , proclaimed at gothenburg on 17 november 2017 , of which principle 10 provides that every worker has the right to healthy , safe and well - adapted work environment . the right to a high level of protection of the health and safety at work , as well as to a working environment adapted to the professional needs of workers and which enables them to prolong their participation in the labour market includes also protection from carcinogens and mutagens at the workplace . __________________ 43 european pillar of social rights , november 2017 , https : / / ec . europa . eu / commission / priorities / deeper - and - fairer - economic - and - monetary - union / european - pillar - social - rights_en


### maximum levels for the exposure of workers to some carcinogens or mutagens are established by values which , pursuant to directive 2004 / 37 / ec , must not be exceeded . ### maximum levels for the exposure of workers to some carcinogens or mutagens are established in annex iii by values which , pursuant to directive 2004 / 37 / ec , must not be exceeded . practical recommendations for the health surveillance of workers may be laid down in annex ii to directive 2004 / 37 / ec but not made mandatory .


### this directive strengthens the protection of workers’ health and safety at their workplace . new limit values should be set out in directive 2004 / 37 / ec in the light of available information , including new scientific and technical data and evidence - based best practices , techniques and protocols for exposure level measurement at the workplace . that information should , if possible , include data on residual risks to the health of workers , recommendations of the scientific committee on occupational exposure limits and opinions of the committee for risk assessment of the european chemicals agency , as well as opinions of the advisory committee on safety and health at work . information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens . transparency of such information should be further encouraged . ### this directive strengthens the protection of workers’ health and safety at their workplace . new limit values should be set out in directive 2004 / 37 / ec in the light of available information , including new scientific and technical data and evidence - based best practices , techniques and protocols for exposure level measurement at the workplace . that information should , if possible , include data on residual risks to the health of workers , recommendations of the scientific committee on occupational exposure limits , opinions of the committee for risk assessment of the european chemicals agency , opinions of the advisory committee on safety and health at work and monographs of the international agency for research on cancer . information related to residual risk , made publicly available at union level , is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens . transparency of such information should be further encouraged . __________________ 1a the international agency for research on cancer was set up in 1965 by the united nations world health organization .


### it is also necessary to consider other absorption pathways than inhalation of all carcinogens and mutagens , including the possibility of uptake through the skin , in order to ensure the best possible level of protection . amendments to annex iii to directive 2004 / 37 / ec provided for in this directive constitute a further step in a longer term process initiated to update directive 2004 / 37 / ec . ### it is also necessary , in the light of scientific data , to consider other absorption pathways than inhalation of all carcinogens and mutagens , in view of observations regarding the possibility of uptake through the skin - concretely through skin notation , greater sensitivity of the skin or respiratory tracts and respiratory and skin sensitisation - in order to ensure the best possible level of protection . amendments to annex iii to directive 2004 / 37 / ec provided for in this directive constitute a further step in a longer term process initiated to update directive 2004 / 37 / ec .


### 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 small and medium - sized undertakings . member states are therefore invited to assess the impact of their transposition act on smes in order to make sure that smes are not disproportionately affected , with specific attention for micro - enterprises and for administrative burden , and to publish the results of such assessments . ### in implementing this directive member states should take the everyday existence of small and medium - sized undertakings into account . member states are therefore invited to assess the impact of their transposition act on smes in order to make sure that smes are not disproportionately affected , with specific attention for micro - enterprises and for administrative burden , and to publish the results of such assessments .


### the agency should develop and maintain a high level of expertise and operate as a point of reference establishing trust and confidence in the single market by virtue of its independence , the quality of the advice it delivers and the information it disseminates , the transparency of its procedures and methods of operation , and its diligence in carrying out its tasks . the agency should proactively contribute to national and union efforts while carrying out its tasks in full cooperation with the union institutions , bodies , offices and agencies and the member states . in addition , the agency should build on input from and cooperation with the private sector as well as other relevant stakeholders . a set of tasks should establish how the agency is to accomplish its objectives while allowing flexibility in its operations . ### the agency should develop and maintain a high level of expertise and operate as a point of reference establishing trust and confidence in the single market by virtue of its independence , the quality of the advice it delivers and the information it disseminates , the transparency of its procedures and methods of operation , and its diligence in carrying out its tasks . the agency should proactively contribute to national and union efforts while carrying out its tasks in full cooperation with the union institutions , bodies , offices and agencies and the member states , avoiding any duplication of work , promoting synergy and complementarity and thus achieving coordination and fiscal savings . in addition , the agency should build on input from and cooperation with the private sector as well as other relevant stakeholders . a set of tasks should establish how the agency is to accomplish its objectives while allowing flexibility in its operations .


### the agency shall promote cooperation and coordination at union level among member states , union institutions , agencies and bodies , and relevant stakeholders , including the private sector , on matters related to cybersecurity . ### the agency shall promote cooperation and coordination at union level among member states , union institutions , agencies and bodies , and relevant stakeholders , including the private sector , on matters related to cybersecurity in order to achieve coordination and financial savings , to avoid duplication and to promote synergy and complementarity as regards their activities .