### it does not , on the basis of the scientific evidence available , pose a safety concern to the health of the consumer ; ### it does not , on the basis of the scientific evidence available , pose a safety concern to the health of the consumer and of animals , which implies that cumulative and synergistic effects as well as possible adverse effects on particular groups of the population will be taken into account in the risk assessment ;


### if it is intended to replace another food , it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer . ### in the case where it is intended to replace another food , it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer .


### the union list shall be updated in accordance with the procedure laid down in regulation no 1331 / 2008 and , where applicable , in accordance with article 16 of this regulation . ### the commission shall update the union list , inter alia in cases of data protection referred to in article 16 , in accordance with the procedure laid down in regulation no 1331 / 2008 . by way of derogation from paragraphs 4 to 6 of article 7 of regulation no 1331 / 2008 , the regulation updating the union list shall be adopted by means of delegated acts in accordance with article 21 and subject to the conditions of articles 22 and 23 . the commission shall publish the union list on a dedicated page of its website .


### the entry for a novel food in the union list shall include a specification of the food , and , where appropriate , specify the conditions of use , additional specific labelling requirements to inform the final consumer , and / or a post - market monitoring requirement and , where applicable , the information referred to in article 16 . ### the entry of a novel food in the union list shall include : a specification of the food ; the intended use of the food ; the conditions of use ; the date of entry of the novel food in the union list and the date of receipt of the application ; the name and address of the applicant ; the date and results of the last inspection according to the monitoring requirements laid down in article 14 ; the fact that the entry is based on newly developed scientific evidence and / or proprietary data protected in accordance with article 16 ; the fact that the novel food may only be placed on the market by the applicant specified in point , unless a subsequent applicant obtains authorisation for the food without prejudice to the proprietary data of the original applicant .


### at any stage of the procedure the interested party may withdraw its application . 7 . by . . …* , the commission shall adopt detailed rules for the implementation of this article in accordance with the regulatory procedure referred to in article 19 . * oj : please insert date : 2 years after the entry into force of this regulation . ### in order to ensure smooth functioning of the notification procedure provided for in this article , the commission shall , before . . . * , adopt detailed rules on the application of this article by means of delegated acts in accordance with article 21 and subject to the conditions of articles 22 and 23 . * six month after the date of entry into force of this regulation


### procedure for including a traditional food from a third country in the list by way of derogation from the procedure laid down in article 9 of this regulation , an interested party referred to in article 3 of regulation no 1331 / 2008 , who intends to place on the market within the union a traditional food from a third country , shall submit an application to the commission . the application shall include : the name and description of the food , its composition , its country of origin , documented data demonstrating the history of safe food use in any third country , where applicable , the conditions of use and specific labelling requirements , a summary of the content of the application . the application shall be made in accordance with the implementing rules referred to in paragraph 7 of this article . 2 . the commission shall forward the valid application referred to in paragraph 1 without delay to the member states and the authority . 3 . within six months of receipt of an application , the authority shall give its opinion . whenever the authority seeks supplementary information from the interested party , it shall , after consulting the interested party , lay down a period within which that information shall be provided . the six - month time limit shall be automatically extended by this additional period . the supplementary information shall be made available to the member states and the commission by the authority . 4 . in order to prepare its opinion the authority shall verify that : the history of safe food use in any third country is substantiated by the quality of data submitted by the interested party ; and the composition of the food and , where applicable , the conditions of its use , do not pose a health risk to consumers in the union . the authority shall forward its opinion to the commission , the member states and the interested party . 5 . within three months of the authority giving its opinion , the commission shall , in accordance with the regulatory procedure referred to in article 19 , update the list of traditional foods from third countries , taking account of the opinion of the authority , any relevant provisions of union law and any other legitimate factors relevant to the matter under consideration . the commission shall inform the interested party accordingly . if the commission decides not to proceed with an update of the list of traditional foods from third countries , it shall inform the interested party and the member states accordingly , indicating the reasons for not considering the update justified . 6 . at any stage of the procedure the interested party may withdraw its application . 7 . by . . … , the commission shall adopt detailed rules for the implementation of this article in accordance with the regulatory procedure referred to in article 19 . ### traditional food from a third country a food business operator intending to place a traditional food from a third country on the market in the union shall notify this to the commission , indicating the name of the food , its composition and country of origin . the notification shall be accompanied by documented data demonstrating the history of safe food use in any third country . 2 . the commission shall forward the notification including the demonstration of history of safe food use referred to in paragraph 1 without delay to the member states and the authority and make it publicly available on its website . 3 . within four months from the date on which the notification provided for in paragraph 1 is forwarded by the commission according to paragraph 2 , a member state and the authority may inform the commission that they have justified safety objections , based on scientific evidence , to the placing on the market of the traditional food concerned . in that case , the food shall not be placed on the market in the community and articles 5 a - 9 shall apply . the notification as referred to in paragraph 1 of this article shall be considered as an application referred to in article 3 of regulation no 1331 / 2008 . alternatively , the applicant may choose to withdraw the notification . the commission shall inform the food business operator concerned accordingly without undue delay and in a demonstrable manner within no more than five months from the date of the notification provided for in paragraph 1 . 4 . if no justified safety objections , based on scientific evidence , have been raised and no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3 , the traditional food may be placed on the market in the union after five months from the date of the notification in accordance with paragraph 1 . 5 . the commission shall publish a list of traditional foods from third countries that may be placed on the market in the union in accordance with paragraph 4 on a dedicated page of the commission ' s website . this page shall be accessible from and linked to the page on the union list of novel foods referred to in article 5 a . 6 . before . . . * , detailed rules for the implementation of this article , designed to amend non - essential elements of this regulation , inter alia by supplementing it , shall be adopted in accordance with . . . . . * six months after the date of entry into force of this regulation .


### without prejudice to the provisions under point of article 9 of regulation no 1331 / 2008 and by . … , the commission shall , where appropriate , in close cooperation with the authority and after consultation with interested parties , make available technical guidance and tools to assist interested parties in preparing and submitting applications under this regulation ; in particular , food business operators , especially small and medium - sized enterprises . ### without prejudice to the provisions of article 9 a of regulation no 1331 / 2008 and before . . . * , the commission shall , where appropriate , in close cooperation with the authority , the food business operators and small and medium - sized enterprises make available technical guidance and tools to assist food business operators and especially small and medium - sized enterprises in preparing and submitting applications under this regulation . commission recommendation 97 / 618 / ec of 29 july 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under regulation no 258 / 97 of the european parliament and of the council26 shall be available for use by applicants until replaced by revised technical guidance issued in accordance with this article . the technical guidance and tools shall be published , not later than . . . ** , on a publicly accessible page intended for that purpose on the website of the commission . * six months after the date of entry into force of this regulation . 26 oj l 253 , 16 . 9 . 1997 , p . 1 . ** six months after the date of entry into force of this regulation .


### in assessing the safety of novel foods , where appropriate , the authority shall , in particular : ### in assessing the safety of novel foods , the authority shall , on the basis of the requirements specified in article 6 :


### consider whether the food is as safe as food from a comparable food category already existing on the market within the union or as safe as the food that the novel food is intended to replace ; ### consider whether the new food , irrespective of whether or not it is intended to replace a food already existing on the market , poses any risk of harmful or toxic effects to human health , while also taking into account the implications of any new characteristics ;


### take into account the history of safe food use . ### take into account for traditional food from a third country , the history of safe food use .


### special obligations on food business operators the commission may , for food safety reasons and following the opinion of the authority , impose a requirement for post - market monitoring . the food business operator placing the food on the market within the union shall be responsible for fulfilling the post marketing requirements specified in the entry of the food concerned in the community list of novel foods . ### obligations on the food business operators the commission shall impose for food safety reasons and following the opinion of the authority , a requirement for post - market monitoring . this monitoring shall take place five years after the date of inclusion of a novel food in the union list and take into account food safety aspects as well as animal health and welfare aspects and the environmental impact . special attention shall be paid to the categories of the population with the highest dietary intakes .


### european group on ethics in science and new technologies the commission , on its own initiative or at the request of a member state , may consult the european group on ethics in science and new technologies , with a view to obtaining its opinion on ethical questions relating to science and new technologies of major ethical importance . the commission shall make this opinion available to the public . ### european group on ethics and new technologies where appropriate , the commission may , on its own initiative or at the request of a member state , consult the european group on ethics and new technologies , with a view to obtaining its opinion on ethical questions relating to science and new technologies of major ethical importance . the commission shall make that opinion of the european group on ethics and new technologies available to the public .


### authorisation procedure in cases of data protection on request by the applicant , supported by appropriate and verifiable information included in the application dossier , newly developed scientific evidence and / or scientific data supporting the application may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the union list without the agreement of the prior applicant . this protection shall be granted where : ### data protection at the request of the applicant , supported by appropriate and verifiable information included in the application dossier , newly developed scientific evidence and proprietary scientific data provided to support the applications may not be used for the benefit of another application for a period of five years from the date of the inclusion of the novel food in the union list unless the subsequent applicant has agreed with the prior applicant that such data and information may be used , and where :


### the prior applicant had exclusive right of reference to the proprietary scientific data at the time the first application was made ; and ### the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made ; and


### the novel food could not have been authorised without the submission of the proprietary scientific data by the prior applicant . ### the novel food could not have been authorised without the submission of the proprietary data by the prior applicant .


### member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . member states shall notify those provisions to the commission by … and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provision of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission within 12 months from the entry into force and shall , without delay , notify it of any subsequent amendment affecting them .


### the power to adopt the delegated acts referred to in article 20 shall be conferred on the commission for a period of five years following the entry into force of this regulation . the commission shall make a report in respect of the delegated powers at the latest six months before the end of the five - year period . the delegation of power shall be automatically extended for periods of an identical duration , unless the european parliament or the council revokes it in accordance with article 22 . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the power to adopt delegated acts are conferred on the commission subject to the conditions laid down in articles 22 and 23 . ### the power to adopt the delegated acts referred to in articles 2 , 3 , 4 , 4 , 9 , 11 and 20 shall be conferred on the commission for a period of five years following the entry into force of this regulation . the commission shall make a report in respect of the delegated powers at the latest six months before the end of the five - year period . the delegation of power shall be automatically extended for periods of an identical duration , unless the european parliament or the council revokes it in accordance with article 22 . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the power to adopt delegated acts are conferred on the commission subject to the conditions laid down in articles 22 and 23 .


### the delegation of power referred to in article 20 may be revoked at any time by the european parliament or by the council . 2 . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall inform the other institution and the commission at the latest one month before the final decision is taken , stating the delegated powers which could be subject to revocation and the reasons for a revocation . 3 . the decision of revocation shall put an end to the delegation of the powers specified in that decision . it shall take effect immediately or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . it shall be published in the official journal of the european union . ### the delegation of power referred to in articles 2 , 3 , 4 , 4 , 9 , 11 and 20 may be revoked at any time by the european parliament or by the council . 2 . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the commission within a reasonable time before the final decision is taken , indicating the delegated powers which could be subject to revocation and possible reasons for a revocation . 3 . the decision of revocation shall put an end to the delegation of the powers specified in that decision . it shall take effect immediately or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . it shall be published in the official journal of the european union .


### the european parliament or the council may object to the delegated act within a period of three months from the date of notification . 2 . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act , or if , before that date , the european parliament and the council have both informed the commission that they have decided not to raise objections , the delegated act shall enter into force on the date stated therein . 3 . if the european parliament or the council objects to the delegated act , it shall not enter into force . the institution which objects shall state the reasons for objecting to the delegated act . ### the european parliament or the council may object to a delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by two months . 2 . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act it shall be published in the official journal of the european union and shall enter into force at the date started therein . the delegated act may be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections . 3 . if the european parliament or the council objects to a delegated act , it shall not enter into force . the institution which objects shall state the reasons for objecting to the delegated act .


### by . . . &#61482 ; and in the light of experience gained , the commission shall submit to the european parliament and to the council a report on the implementation of this regulation and in particular of articles 3 , 11 and 16 , accompanied , where appropriate , by any legislative proposals . ### no later than . . . * and in the light of experience gained , the commission shall forward to the european parliament and to the council a report on the implementation of this regulation and in particular of articles 11 and 16 , accompanied , where appropriate , by any proposals . * three years and six months after the date of entry into force of this regulation .


### by … , the commission shall submit to the european parliament and to the council a report on all aspects of food produced from animals obtained by using a cloning technique and from their offspring , followed , where appropriate , by any legislative proposals . ### no later than . . . * the commission shall forward to the european parliament and to the council a report on all aspects of food produced from animals obtained by using a cloning technique and from their descendants followed , where appropriate , by any legislative proposals . * three years and six months after the date of entry into force of this regulation .


### any request for placing a novel food on the market within the union submitted to a member state under article 4 of regulation no 258 / 97 before &#8230 ; &#8230 ; shall be transformed into an application under this regulation if an initial assessment report provided for under article 6 of regulation no 258 / 97 has not yet been forwarded to the commission , and in cases where the additional assessment report is required in accordance with article 6 or of regulation no 258 / 97 . other pending requests submitted under article 4 of regulation no 258 / 97 before …… shall be processed under the provisions of that regulation . ### any request for placing a novel food on the market submitted to a member state under article 4 of regulation no 258 / 97 in relation to which the initial assessment report provided for under article 6 of that regulation has not yet been forwarded to the commission before . . . shall be considered as an application under this regulation . other requests submitted under articles 3 , 4 and 5 of regulation no 258 / 97 before . . . shall be processed under the provisions of regulation no 258 / 97 .


### in article 1 , paragraphs 1 and 2 are replaced by the following : ' 1 . this regulation lays down a common procedure for the assessment and authorisation of food additives , food enzymes , food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs and novel foods which contributes to the free movement of food within the union and to a high level of protection of human health and to a high level of consumer protection , including the protection of consumer interests . this regulation shall not apply to smoke flavourings falling within the scope of regulation no 2065 / 2003 of the european parliament and of the council of 10 november 2003 on smoke flavourings used or intended for use in or on foods . 2 . the common procedure shall lay down the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the union pursuant to regulation no 1333 / 2008 , regulation no 1332 / 2008 , regulation no 1334 / 2008 and regulation no … / … of the european parliament and of the council of … on novel foods . ### in article 1 , paragraphs 1 and 2 are replaced by the following : ' 1 . this regulation lays down an assessment and authorisation procedure for food additives , food enzymes , food flavourings and sources of food flavourings used or intended for use in or on foodstuffs and novel foods , which contributes to the free movement of foods within the union and to a high level of protection of human health and protection of consumers ' interests . 2 . the procedure shall set the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the union pursuant to regulation no 1333 / 2008 , regulation no 1332 / 2008 , regulation no 1334 / 2008 and regulation no . . . / 2009 of the european parliament and of the council of . . . on novel foods . '


### in article 1 , article 2 and , , article 9 , article 12 and article 13 the words ' substance ' and ' substances ' are replaced by ' substance or product ' or ' substances or products ' as appropriate . ### in article 1 paragraph 3 , article 2 paragraphs 1 and 2 , article 9 paragraph 2 , article 12 paragraph 1 and article 13 the word ' substance ' or ' substances ' is replaced by ' substance or product ' or ' substances or products ' .


### however , articles 26 , 27 and 28 shall apply from … . furthermore , by way of derogation from the second paragraph of this article and by way of derogation from the second paragraph of article 16 of regulation no 1331 / 2008 , applications may be made in accordance with this regulation as from …** for the authorisation of food referred to in point of article 3 of this regulation , where such food is already on the market within the union at that date . ### however , article 26 shall apply from . . . ** . ** the date of entry into force of this regulation .


### noise assessments should build on existing information available and ensure that such information is reliable and accessible to competent authorities and stakeholders . competent authorities should put in place the necessary monitoring and enforcement tools . ### noise assessments should be based on objective and measurable criteria common to all the member states . they should be accessible to all stakeholders . competent authorities should put in place the necessary monitoring and enforcement tools . noise assessments should involve consultations of local residents and be carried out or supervised by outside agencies independent of the airport operator .


### to enable selection of the most cost - effective noise mitigation measures in accordance with the balanced approach so as to achieve the sustainable development of the airport and air traffic management network capacity from a gate - to - gate perspective . ### to enable selection of effective noise mitigation measures , so as to achieve , in the light of the balanced approach , improved neighbourhood noise protection consistent with the sustainable development of the airport and air traffic management network capacity .


### competent authorities ### competent authorities , consultation and right to take legal action


### land - use planning and management ; ### regional land - use planning and management ;


### noise abatement operational procedures ; ### noise abatement operational procedures , including changes to landing and take - off routes ;


### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to achieve the environmental noise abatement objectives set for that airport . operating restrictions shall be non - discriminatory , in particular on grounds of nationality , identity or activity of aircraft operators . ### measures or a combination of measures taken in accordance with this regulation for a given airport must be suitable to achieve at least the environmental noise abatement objectives set for that airport .


### the competent authorities shall ensure that , at the appropriate level , a forum for technical cooperation is established between the airport operator , aircraft operator and air navigation service provider , for actions which these operators are responsible for , and taking due account of the interdependency between measures to mitigate noise and to reduce emissions . the members of this forum for technical cooperation shall regularly consult local residents or their representatives , and provide technical information and advice on noise mitigating measures to the competent authorities . ### the competent authorities shall establish a consultation forum which brings together the airport operator , the aircraft operator , representatives of the air navigation service provider and representatives of local residents . planning , technical and organisational measures to mitigate noise and reduce emissions shall be discussed in this forum .


### the competent authorities shall assess the cost - effectiveness of the new measures , as referred to in paragraph 3 in accordance with annex ii . a minor technical amendment to an existing measure without substantive implications on capacity or operations is not considered as a new operating restriction . ### the competent authorities shall assess new measures as referred to in paragraph 3 in the light of the information in annex ii .


### direct , indirect and catalytic employment effects . ### direct and indirect employment effects .


### ‘ the credit rating is issued with respect to a rated entity or a related third party which directly or indirectly holds 10% or more of either the capital or the voting rights of that credit rating agency ; ’ ; ### ‘ the credit rating is issued with respect to a rated entity or a related third party which , either directly or indirectly , is a holder of capital or voting rights in that credit rating agency ; ’ ;


### the rights inherent to citizenship of the union are incorporated in the charter of fundamental rights of the european union . according to the charter ' s preamble , the union ' places the individual at the heart of its activities , by establishing a citizenship of the union and by creating an area of freedom , security and justice ' . chapter v of the charter sets down ' citizens ' rights ' , including , in its article 45 , the right of every citizen of the union to move and reside freely within the territory of the member states . ### the rights inherent to citizenship of the union are incorporated in the charter of fundamental rights of the european union . according to the charter ' s preamble , the union ' is founded on the indivisible , universal values of human dignity , freedom , equality and solidarity ' and ' places the individual at the heart of its activities , by establishing the citizenship of the union and by creating an area of freedom , security and justice ' . chapter v of the charter sets down ' citizens ' rights ' , including , in its article 45 , the right of every citizen of the union to move and reside freely within the territory of the member states , and this right may be granted , in accordance with the treaties , to nationals of third countries legally resident in the territory of a member state .


### despite the fact that the right to free movement and residence is firmly anchored in primary union law and substantially developed in secondary law , a gap still remains between the applicable legal rules and the reality confronting citizens when they seek to exercise this right in practice . aside from an uncertainty over the advantages of being mobile , union citizens perceive too many practical obstacles with regard to living and working elsewhere in the union . ### despite the fact that the right to free movement and residence is firmly anchored in primary union law and substantially developed in secondary law and despite the union programmes aimed at promoting the free movement of workers or job mobility , a gap still remains between the applicable legal rules and the reality confronting citizens when they seek to exercise this right in practice . aside from an uncertainty over the advantages of being mobile , union citizens perceive too many practical obstacles and often face difficulties relating to their nationality , social and marital status or citizenship , due to unacceptable legal and administrative measures imposed by the member states which are not prescribed by union rules , or are interpreted in a manner contrary to union law with regard to living and working elsewhere in the union .


### however , to enable union citizens to make informed decisions about whether to exercise their right to free movement , it does not suffice to raise their awareness about the right to free movement itself ; it is essential that union citizens are also adequately informed about other rights available to them under union law in a cross - border context . this information will also enable them to fully enjoy these rights , if they decide to make use of their right to free movement . ### however , to enable union citizens to make informed decisions about whether to exercise their right to free movement , it does not suffice to raise their awareness about the right to free movement itself ; it is essential that union citizens are also adequately informed about their labour rights available to them under union labour law in a cross - border context . this information will also enable them to fully enjoy these rights and to protect their labour rights , without discrimination , so that free movement is never exploited with a view to unequal treatment , or to wage and social dumping .


### - to raise union citizens ' awareness of how they can tangibly benefit from union rights and policies while living in another member state , and to stimulate their active participation in civic fora on union policies and issues ; ### - to raise union citizens ' awareness of how they can tangibly benefit from union rights and policies while living and working in another member state , and to stimulate their active participation in civic fora on union policies and issues ;


### - to stimulate a debate about the impact and potential of the right to free movement , as an inalienable aspect of union citizenship , in particular in terms of strengthening societal cohesion and mutual understanding between union citizens and the bond between citizens and the union . ### - to stimulate a debate about the impact and potential of the right to free movement , as an inalienable aspect of union citizenship , without discrimination on the grounds of nationality or ethnic origin , in particular in terms of strengthening societal cohesion and mutual understanding between union citizens and the bond between citizens and the union .


### - conferences and events to promote debate and raise awareness of the importance and benefits of the right to free movement and residence and more generally citizens ' rights as union citizens ; ### - conferences and events to promote debate and raise awareness of the importance and benefits of the right to free movement and residence and more generally citizens ' rights as union citizens , including the rights of third - country family members accompanying or joining union citizens moving to another member state ;


### - strengthening of the role and visibility of the multilingual europe direct and your europe web portal as key elements of a ' one - stop - shop ' information system on union citizens ' rights ; ### - strengthening of the role and visibility of the multilingual europe direct , your europe and eures web portal as key elements of a ' one - stop - shop ' information system on union citizens ' rights and information on workers ' and their families rights in the relevant country of employment , as well as initiatives such as youth on the move ;


### open data policies which encourage the wide availability and re - use of public sector information for private or commercial purposes , with minimal or no legal , technical or financial constraints , can play an important role in kick - starting the development of new services based on novel ways to combine and make use of such information . however , this requires a level playing field at union level in terms of whether or not the re - use of documents is authorised , which cannot be achieved by leaving it up to the different rules and practices of the member states or the public bodies concerned . ### open data policies which encourage the availability and re - use of public sector information for private or commercial purposes , with minimal or no legal , technical or financial constraints , and which promote the circulation of information not only for economic operators but also for members of the public and the free movement of persons within the union , with due regard for fundamental rights in every case , can play an important role in kick - starting the development of new services based on novel ways to combine and make use of such information . however , this requires a level playing field at union level in terms of whether or not the re - use of documents is authorised , which cannot be achieved by leaving it up to the different rules and practices of the member states or the public bodies concerned .


### the scope of application of the directive is extended to libraries , museums and archives . the directive does not apply to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions . ### the scope of application of the directive is extended to libraries , museums and archives . the directive does not apply to research and education establishments or to other cultural institutions , such as operas , ballets or theatres , including the archives that are part of these institutions .


### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### proper implementation of some of the features of this directive , such as means of redress , especially for private individuals with regard to data protection , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### since the objective of this directive , namely to facilitate the creation of union - wide information products and services based on public sector documents , to ensure the effective cross - border use of public sector documents by private companies for added - value information products and services , and to limit distortions of competition on the union market , cannot be sufficiently achieved by member states and can therefore , in view of the intrinsic pan - european scope of the proposed action , be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the functioning of the european union . in accordance with the principles of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives . ### since the objective of this directive , namely to facilitate the creation of union - wide information products and services based on public sector documents , to ensure the effective cross - border use of public sector documents on the one hand by private companies for added - value information products and services and on the other hand by citizens to facilitate the free circulation of information and communication , cannot be sufficiently achieved by member states and can therefore , in view of the intrinsic pan - european scope of the proposed action , be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the functioning of the european union . in accordance with the principles of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives .


### the marketing authorisation holders may not refuse reports of suspected adverse reactions received electronically from patients and health - care professionals . ### the marketing authorisation holders must forward to the national competent authorities any reports of suspected adverse reactions received from patients and health - care professionals within 7 days following the receipt of the report . the marketing authorisation holder must inform the patient and health - care professional that their report has been forwarded to the competent authorities who will be in charge of the follow up . member states shall , as appropriate , involve patients and health - care professionals in the follow up of any reports they receive . the national competent authorities may not refuse any reports of suspected adverse reactions received via post , telephone , fax or in electronic format from patients and healthcare professionals .


### the esf should improve employment opportunities , promote education and life - long learning and develop active inclusion policies in accordance with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty . in accordance with article 9 of the treaty , the esf should take into account requirements linked to the promotion of a high level of employment , the guarantee of adequate social protection , the fight against social exclusion , and a high level of education , training and protection of human health . ### the esf should provide the support required for policies to promote employment with rights , play a major role in strengthening social inclusion , and promote education and lifelong learning in accordance with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty ; that being the case , the amounts available under it need to be increased substantially . in accordance with article 9 of the treaty , the esf should take into account requirements linked to the promotion of a high level of employment , the guarantee of social protection accessible to all , the fight against social exclusion , and a high level of education , training and protection of human health .


### the european council of 17 june 2010 called for all common policies , including cohesion policy , to support the europe 2020 strategy for smart , sustainable and inclusive growth ‘ 12 . in order to ensure the full alignment of the esf with the objectives of this strategy , particularly as regards employment , education , and the fight against social exclusion , the esf should support member states in implementing the council recommendations on broad guidelines for economic policies of the member states and the union and the council decisions on guidelines for the employment policies of the member states adopted in accordance with articles 121 and 148 of the treaty . it should also contribute to the implementation of the flagship initiatives , with special regard to the ’agenda for new skills and jobs ‘ 13 , ’youth on the move ‘ 14 , and the ’european platform against poverty and social exclusion ‘ 15 . it will also support the activities in the ’digital agenda ‘ 16 and the ’innovation union ‘ 17 initiatives . ### the european council of 17 june 2010 called for all common policies , including cohesion policy , to support the europe 2020 strategy for smart , sustainable and inclusive growth ' 12 . in order to ensure the full alignment of the esf with the objectives of this strategy , particularly as regards employment , education , and the fight against poverty and social exclusion , the esf should support member states in their efforts to achieve those objectives . it should also support the implementation of the flagship initiatives , with special regard to the ' agenda for new skills and jobs ' 13 , ' youth on the move ' 14 , and the ' european platform against poverty and social exclusion ' 15 . it should also support the activities in the ' digital agenda ' 16 and the ' innovation union ' 17 initiatives .


### the european union is confronted with structural challenges arising from economic globalisation , technological change and an increasingly ageing workforce and growing skills and labour shortages in some sectors and regions . they have been compounded by the recent economic and financial crisis , which has resulted in increased levels of unemployment , hitting in particular young people and other vulnerable groups , such as migrants . the esf should aim to promote employment and support labour mobility , invest in education , skills and life - long learning , promote social inclusion and combat poverty . in promoting the better functioning of labour markets by enhancing the transnational geographical mobility of workers , the esf should , in particular , support european employment services in relation to recruitment and the related information , advice and guidance services at national and cross - border level . ### the european union is confronted with structural challenges arising from economic globalisation , technological change and an increasingly ageing workforce and growing skills and labour shortages in some sectors and regions . they have been compounded by the recent economic and financial crisis , which has resulted in increased levels of unemployment , hitting in particular young people and other vulnerable groups , such as migrants . the esf should aim to promote employment with rights and support labour mobility , invest in education , skills and lifelong learning , promote social inclusion and combat poverty . the esf may support european employment services in relation to recruitment and the related information , advice and guidance services at national and cross - border level .


### it shall do so by supporting member states in pursuing the priorities and headline targets of the europe 2020 strategy for smart , sustainable and inclusive growth . the esf shall support the design and implementation of policies and actions , taking account of the integrated guidelines for the economic and employment policies of member states19 and the council recommendations on the national reform programmes . ### it shall do so by supporting member states in pursuing at least the headline targets of the europe 2020 strategy for smart , sustainable and inclusive growth . the esf shall support the design and implementation of policies and actions , taking account of the concept of ' good work ' and ensuring that activities supported by the esf contribute to implementing the un and ilo decent work agenda in all its aspects . all policies and actions supported by the esf shall strictly respect international labour standards and ilo conventions , and in particular the commitment to promote full , productive and freely chosen employment as laid down by ilo convention no . 122 .


### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised communities and people facing social exclusion . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education and social policies . ### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , asylum seekers , refugees , ethnic minorities , marginalised communities , homeless people and other groups of people at risk of poverty and social exclusion , including children and young people . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and social progress , in particular in the fields of employment , education and social policies .


### enhancing the competitiveness of small and medium - sized enterprises , through promoting the adaptability of enterprises and workers and increased investment in human capital . ### enhancing the contribution of small and medium - sized enterprises to achieve environmentally and socially sustainable development , through promoting the adaptability of enterprises and workers and increased investment in new skills and competencies .


### the member states and the commission shall promote equality between men and women through mainstreaming as referred to in article 7 of regulation no [ … ] and specific targeted actions as referred to in article 3 , in particular with the aim of increasing the sustainable participation and progress of women in employment , reducing gender - based segregation in the labour market , combating gender stereotypes in education and training and promoting reconciliation of work and personal life for men and women . ### the member states and the commission shall promote equality between women and men through mainstreaming as referred to in article 7 of regulation no [ … ] integrating gender perspective to actions under all thematic priorities and to all stages of planning and implementation of programmes . the member states shall allocate funding for and specific targeted actions as referred to in article 3 , in particular with the aim of increasing the sustainable participation and progress of women in employment , eliminating gender - based segregation in the labour market , combating gender stereotypes in education and training , addressing the feminisation of poverty , promoting equal sharing of care responsibilities between women and men and enforcing reconciliation of work and personal life for women and men .


### by way of derogation from article 110 of regulation no [ … ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to social innovation or to transnational cooperation , or a combination of both . ### by way of derogation from article 110 of regulation no [ . . . ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to transnational cooperation , or a combination of both .


### in the light of the results of the evaluation conducted by the commission on the reform of public procurement rules it is appropriate to exclude from the full application of this directive only those services which have a limited cross - border dimension , namely the so - called services to the person such as certain social , health and educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a specific regime should therefore be established for concession for these services which takes into account the fact that they are newly regulated . an obligation to publish a prior information notice and a concession award notice of any concession with a value equal to or greater than thresholds established in this directive is an adequate way to provide information on business opportunities to potential tenderers as well as on the number and type of contracts awarded to all interested parties . furthermore , member states should put in place appropriate measures with reference to the award of concession contracts for these services aimed at ensuring compliance with the principles of transparency and equal treatment of economic operators while allowing contracting authorities and contracting entities to take into account the specificities of the services in question . member states should ensure that contracting authorities and contracting entities may take into account the need to ensure quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , the involvement and empowerment of users and innovation . ### those services of general interest that address people’s basic needs shall be excluded from the application of this directive : for example , municipal water supply and wastewater disposal services , refuse handling services and services such as social , health , cultural and educational services . these services are provided within a particular context that varies widely amongst member states , due to different cultural traditions . a specific regime should therefore be established for concession for these services which takes into account the fact that they are newly regulated . an obligation to publish a prior information notice and a concession award notice of any concession with a value equal to or greater than thresholds established in this directive is an adequate way to provide information on business opportunities to potential tenderers as well as on the number and type of contracts awarded to all interested parties . furthermore , member states should put in place appropriate measures with reference to the award of concession contracts for these services aimed at ensuring compliance with the principles of transparency and equal treatment of economic operators while allowing contracting authorities and contracting entities to take into account the specificities of the services in question . member states should ensure that contracting authorities and contracting entities may take into account the need to ensure quality , continuity , accessibility , availability and comprehensiveness of the services , the specific needs of different categories of users , the involvement and empowerment of users and innovation .


### in technical specifications and in award criteria , contracting authorities and contracting entities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are linked to the subject - matter of the concession . in order to better integrate social considerations in the award of concessions , procurers may also be allowed to include , in the award criteria , characteristics related to the working conditions . however , where the contracting authorities or contracting entities use the most economically advantageous tender , such criteria may only relate to the working conditions of the persons directly participating in the process of production or provision in question . those characteristics may only concern the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . in this case , any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment . they should be applied in accordance with directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other member states or from third countries parties to the agreement or to free trade agreements to which the union is party . contracting authorities and contracting entities should , also where they use the criterion of the most economically advantageous tender , be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the concession in question , as this may affect the quality of concession performance and , as a result , the economic value of the tender . ### in technical specifications and in award criteria , contracting authorities and contracting entities should be allowed to refer to a specific production process , a specific mode of provision of services , or a specific process for any other stage of the life cycle of a product or service , provided that they are linked to the subject - matter of the concession . in order to better integrate social considerations in the award of concessions , procurers may also be allowed to include , in the award criteria , characteristics related to working conditions , the protection of health or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract , including accessibility for persons with disabilities . contracting authorities and contracting entities should , also where they use the criterion of the most economically advantageous tender , be allowed to use as an award criterion the organisation , qualification and experience of the staff assigned to performing the concession in question , as this may affect the quality of concession performance and , as a result , the economic value of the tender .


### the duration of the concession shall be limited to the time estimated to be necessary for the concessionaire to recoup the investments made in operating the works or services together with a reasonable return on invested capital . ### when awarding the concession the contracting authority or contracting entity may , in the light of the nature of the concession and of the proportionality principle , limit its duration . among the factors that may be considered here is the time estimated to be necessary for the concessionaire to recoup the investments made in operating the works or services . account may also be taken of other objective criteria such as the public interest in ongoing high - quality provision or environmentally and socially sustainable performance of the service , and the expenditure incurred in selecting a concessionaire .


### any economic operator shall be excluded from participation in a concession where the contracting authority or contracting entity is aware of a decision having the force of res judicata establishing that it has not fulfilled obligations relating to the payment of taxes or social security contributions in accordance with the legal provisions of the country in which it is established or with those of the member state of the contracting authority or entity . ### any economic operator shall be excluded from participation in a concession where the contracting authority or contracting entity is aware of a decision having the force of res judicata , or of a legally binding administrative decision , establishing that it has not fulfilled obligations relating to the payment of taxes or social security contributions in accordance with the legal provisions of the country in which it is established or with those of the member state of the contracting authority or entity , or if such an operator has been the subject on more than one occasion of an unfavourable ruling or penalty under employment law .


### member states may provide that contracting authorities or contracting entities exclude from participation in a concession award any economic operator if one of the following conditions is fulfilled : ### member states shall provide that contracting authorities or contracting entities exclude from participation in a concession award any economic operator if one of the following conditions is fulfilled :


### member states may provide that contracting authorities and contracting entities shall base the award of concessions on the criterion of the most economically advantageous tender , in compliance with paragraph 2 . those criteria may include , in addition to price or costs , any of the following criteria ### member states shall provide that contracting authorities and contracting entities shall base the award of concessions on the criterion of the most economically advantageous tender , in compliance with paragraph 2 . those criteria shall include , in addition to price or costs , any of the following criteria


### paragraph 1 shall be without prejudice to the question of the principal economic operator’s liability . ### paragraph 1 shall be without prejudice to the question of the principal economic operator’s liability and subcontractor liability .


### cpv code 7511000 - 4 and from 85000000 - 9 to 85323000 - 9 75121000 - 0 , 75122000 - 7 , 75124000 - 1 75300000 - 9 75310000 - 2 , 75311000 - 9 , 75312000 - 6 , 75313000 - 3 , 75313100 - 4 , 75314000 - 0 , 75320000 - 5 , 75330000 - 8 , 75340000 - 1 98000000 - 3 98120000 - 0 98131000 - 0 ### description health and social services administrative educational , healthcare and cultural services compulsory social security services benefit services other community , social and personal services services furnished by trade unions religious services


### the civil protection mechanism constitutes a visible expression of european solidarity by ensuring a practical and timely contribution to prevention of and preparedness for disasters and the response to major disasters and imminence thereof . this decision should therefore not affect the reciprocal rights and obligations of the member states under bilateral or multilateral treaties , which relate to the matters covered by this decision , nor member states’ responsibility to protect people , the environment and property on their territory . ### the civil protection mechanism constitutes a visible expression of european solidarity by ensuring a practical integrated , effective and timely contribution to prevention of and preparedness for disasters and the response to major disasters and imminence thereof . this decision should therefore not affect the reciprocal rights and obligations of the member states under bilateral or multilateral treaties , which relate to the matters covered by this decision , nor member states’ responsibility to protect people , the environment and property on their territory .


### the mechanism should include a general policy framework for union disaster risk prevention actions aimed at achieving a high level of protection and resilience against disasters by preventing or reducing their effects and by fostering a culture of prevention . risk management plans are essential to ensure an integrated approach to disaster management , linking risk prevention , preparedness and response actions . therefore , the mechanism should include a general framework for their communication and implementation . ### the mechanism should include a general policy framework for union disaster risk prevention actions aimed at achieving a high level of protection and resilience against disasters by preventing or reducing their effects and by fostering a culture of prevention . risk management plans are essential to ensure an integrated approach to disaster management , linking risk prevention , preparedness and response actions . therefore , the mechanism should include a general framework for their communication and implementation , whereas the commission should develop general guidelines in order to ease the comparability and integration of member states ' risk management plans .


### where the use of military capacities is considered in support of civil protection operations to be appropriate , cooperation with the military should follow the modalities , procedures and criteria established by the council or its competent bodies for making available to the mechanism military capacities relevant to the protection of civilian populations ### where the use of military capacities under civilian oversight is considered as a last resort necessary to support civil protection operations , while ensuring that disaster relief is never subordinate to trading or political and strategic concerns , cooperation with the military should follow the modalities , procedures and criteria established by the council or its competent bodies , under the oslo guidelines , for making available to the mechanism military capacities relevant to the protection of civilian populations


### facilitate the mobilisation of teams , experts , modules and intervention support other than that from the european emergency response capacity ; ### facilitate and hasten a quick timed mobilisation of teams , experts , modules and intervention support other than that from the european emergency response capacity ;


### the scope of the emff should cover the support of the cfp which extends to conservation , management and exploitation of marine biological resources , fresh water biological resources and - aquaculture , as well as to the processing and marketing of fishery and aquaculture products , where such activities take place on the territory of member states , or in union waters , including by fishing vessels flying the flag of , and registered in , third countries , or by union fishing vessels , or by nationals of member states , without prejudice to the primary responsibility of the flag state , bearing in mind the provisions of article 117 of the united nations convention on the law of the sea . ### the scope of the emff should cover the support of the cfp , which extends to conservation , management and exploitation of marine biological resources , freshwater biological resources and aquaculture , as well as to the processing and marketing of fishery and aquaculture products and to economic activities in the coastal communities most dependent on fishing , where such activities take place on the territory of member states , or in union waters , including by fishing vessels flying the flag of , and registered in , third countries , or by union fishing vessels , or by nationals of member states , without prejudice to the primary responsibility of the flag state , bearing in mind the provisions of article 117 of the united nations convention on the law of the sea .


### the scope of the emff should cover the support to the imp which extends to the development and implementation of coordinated operations and decision - making in relation to the oceans , seas , coastal regions and maritime sectors complementing the different eu policies that touch upon them , notably the common fisheries policies , transport , industry , territorial cohesion , environment , energy and tourism . coherence and integration should be ensured in the management of different sectoral policies within the baltic sea , north sea , celtic seas , bay of biscay and the iberian coast , mediterranean and black sea sea basins . ### the scope of the emff should cover the support to the imp , which extends to the development and implementation of coordinated operations and decision - making in relation to the oceans , seas , coastal regions and maritime sectors complementing the different eu policies that touch upon them , notably the common fisheries policy , transport , industry , territorial cohesion , environment , energy , tourism , and the creation of stable employment with rights . coherence and integration should be ensured in the management of different sectoral policies within the baltic sea , north sea , celtic seas , bay of biscay and the iberian coast , mediterranean and black sea sea basins .


### action by the union should be complementary to action carried out by member states or seek to contribute to that action . in order to ensure significant added value the partnership between the commission and member states should be strengthened through arrangements for the participation of various types of partners with full regard to the institutional competences of the member states . particular attention should be paid to ensuring adequate representation for women and minority groups . this partnership concerns regional , local and other public authorities , as well as other appropriate bodies , including those responsible for the environment and for the promotion of equality between men and women , the economic and social partners and other competent bodies . the partners concerned should be involved in the preparation of partnership contracts , as well as in the preparation , implementation , monitoring and evaluation of programming . ### action by the union should be complementary to action carried out by member states or seek to contribute to that action . in order to ensure significant added value the partnership between the commission and member states should be strengthened through arrangements for the participation of various types of partners with full regard to the institutional competences of the member states . particular attention should be paid to ensuring adequate representation for women and minority groups . this partnership concerns regional , local and other public authorities , as well as other appropriate bodies , including the fishing industry , those responsible for the environment and for the promotion of equality between men and women , the economic and social partners and other competent bodies . the partners concerned should be involved in the preparation of partnership contracts , as well as in the preparation , implementation , monitoring and evaluation of programming .


### in order to increase the competitiveness and economic performance of fishing activities it is vital to stimulate innovation and entrepreneurship . therefore the emff should support innovative operations and business development . ### in order to increase producers’ profitability and the income of fishing operators it is vital to stimulate modernisation and sustainable development of the fishing industry . therefore the emff should support sustainable development of the fisheries sector , including small - scale fisheries .


### investment in human capital is also vital to increase the competitiveness and economic performance of fishing and maritime activities . therefore , the emff should support lifelong learning , co - operation between scientists and fishermen stimulating the dissemination of knowledge as well as for advisory services helping to improve the overall performance and competitiveness of operators . ### investment in human capital is also vital to increase producers’ profitability and the income of fishing operators . therefore , the emff should support young people seeking to enter the industry , vocational training , lifelong learning , cooperation between scientists and fishermen stimulating the dissemination of knowledge as well as advisory services helping to improve the overall performance and profitability of operators .


### the introduction of the transferable fishing concessions systems should make the sector more competitive . consequently , there may be a need for new professional opportunities outside the fishing activities . therefore , the emff should support the diversification and job creation in fishing communities in particular by supporting business start - ups and the reassignment of vessels for maritime activities outside fishing activities of small scale coastal fishing vessels . this last operation seems to be appropriate as the small scale coastal fishing vessels are not covered by the transferable fishing concessions systems . ### there is a need for new professional opportunities in sectors related to fishing . therefore , the emff should support the diversification and job creation in fishing communities in particular by supporting business start - ups .


### investment in human capital is also vital to increase the competitiveness and economic performance of aquaculture activities . therefore , the emff should support lifelong learning and networking stimulating the dissemination of knowledge as well as advisory services helping to improve the overall performance and competitiveness of operators . ### investment in human capital is also vital to increase producers’ profitability and the income of operators involved in aquaculture activities . therefore , the emff should support lifelong learning and networking stimulating the dissemination of knowledge as well as advisory services helping to improve the overall performance and competitiveness of operators .


### promoting sustainable and competitive fisheries and aquaculture ; ### promoting sustainable fisheries and aquaculture ;


### promoting a balanced and inclusive territorial development of fisheries areas ; ### promoting sustainable development of the coastal areas most dependent on fishing and job creation ;


### promotion of economic growth , social inclusion , creation of jobs and supporting labour mobility in coastal and inland communities depending on fishing and aquaculture ; ### promotion of economic growth , social inclusion , and creation of jobs and supporting coastal and inland communities depending on fishing and aquaculture ;


### diversification of fisheries activities into other sectors of maritime economy and growth of maritime economy , including mitigation of climate change . ### support to the fisheries sector and diversification of fisheries activities into other maritime economy sectors and growth of the maritime economy , including mitigation of climate change .


### enhancement of the competitiveness and viability of fisheries , in particular of small scale coastal fleet , and improvement of safety or working conditions ; ### enhancement of producers’ profitability and the viability of fisheries , in particular of the small - scale coastal fleet , and improvement of safety and working conditions ;


### development of new professional skills and lifelong learning ; ### encouraging young people to enter the sector , and development of vocational training , new professional skills , and lifelong learning ;


### the level of employment in fisheries and aquaculture , ### the level of employment in the fisheries sector and in aquaculture ,


### lifelong learning , dissemination of scientific knowledge and innovative practices , and acquisition of new professional skills in particular linked to the sustainable management of marine ecosystems , activities in the maritime sector , innovation and entrepreneurship ; ### young people seeking to enter the sector , vocational training , lifelong learning , dissemination of scientific knowledge and innovative practices , and acquisition of new professional skills in particular linked to the sustainable management of marine ecosystems , activities in the maritime sector , innovation and entrepreneurship ;


### having regard to the treaty establishing the european community , and in particular article 37 and article 299 thereof , ### having regard to the treaty on the functioning of the european union , and in particular article 43 thereof ,


### member states shall set up a list of closed aquaculture facilities in their territory complying with the definition of the article 3 and update that list regularly . the list shall be published on the website set up in accordance with article 4 of the commission regulation no 535 / 2008 . ” ### member states shall set up a list of closed aquaculture facilities in their territory complying with the definition in article 3 and update that list regularly . within six months of the date of entry into force of this regulation the list shall be published on the website set up in accordance with article 4 of commission regulation no 535 / 2008 . ”


### ‘ closed aquaculture facility’ means a facility ### ‘ closed aquaculture facility’ means a land - based facility


### in the case of routine introductions , the release of aquatic organisms into aquaculture facilities shall be allowed without quarantine or pilot release , unless , in exceptional cases , the competent authority decides otherwise on the basis of specific advice given by the advisory committee . movements from a closed aquaculture facility to an open aquaculture facility shall not be regarded as routine . ### in the case of routine introductions , the release of aquatic organisms into aquaculture facilities shall be allowed without quarantine or pilot release , unless , in exceptional cases , the competent authority decides otherwise on the basis of specific advice given by the advisory committee . movements from a closed aquaculture facility to an open aquaculture facility shall be considered as routine or non - routine movements in line with the provisions of articles 6 and 7 .


### this regulation shall enter into force on the day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the 20th day following that of its publication in the official journal of the european union .


### member states shall ensure that victims are provided with the following information , without unnecessary delay , from their first contact with the authority competent to receive a complaint concerning a criminal offence : ### member states shall ensure that victims are provided promptly with the following information , from their first contact with the authority competent to receive a complaint concerning a criminal offence :


### member states shall ensure that victims are notified of their right to receive the following information on their case and that they receive this information where they have expressed such a wish : ### member states shall ensure that victims are promptly notified of their right to receive the following information on their case , unless they have explicitly&#160 ; stated their wish not to receive such information .


### member states shall ensure that police , prosecutors and court staff receive both general and specialist training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful and professional manner . ### professional staff that come into contact with victims and have the opportunity to be involved in a process that begins to repair the harm caused to victims and member states shall ensure that police , prosecutors , court staff , lawyers and any other officials likely to come into contact with victims , receive the necessary support and training to a level appropriate to their contact with victims to sensitise them to the needs of victims and to deal with them in an impartial , respectful , professional , and empowering manner , and to contribute to begin to repair harm and rebuild trust .


### contributions shall only be used to reimburse a percentage of the operating costs of european political parties directly linked to objectives of those parties . contributions shall not be used to grant directly or indirectly any personal advantage , in cash or in kind , to any individual member or staff of a european political party . ### the contributions referred to in article 204a shall only be used to reimburse a percentage of the operating costs of european political parties that are directly linked to objectives of those parties . contributions shall not be used to grant directly or indirectly any personal advantage , in cash or in kind , to any individual member or staff of a european political party .


### european political parties shall respect the maximum co - financing rate established in regulation xx / xxxx . remaining amounts of the previous two years ' contributions may not be used to finance the part which european political parties must provide from their own resources . ### european political parties shall respect the maximum co - financing rate established in regulation xx / xxxx . remaining amounts of the previous two years ' contributions shall not be used to finance the part which european political parties must provide from their own resources . furthermore , services provided or paid by third parties within the context of joint events shall not be taken into account when calculating the european political parties ' share of own resources .


### in electricity : scenarios for demand , generation capacities by fuel type and their geographical location , fuel prices , carbon dioxide prices , the composition of the transmission and , if relevant , the distribution network , and its evolution , taking into account all new significant generation , storage and transmission projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n + 5 ; ### in electricity : scenarios for demand , generation capacities by fuel type and their geographical location , fuel prices , carbon dioxide prices , the composition of the transmission and , if relevant , the distribution network , and its evolution , taking into account all new significant generation , storage and transmission projects for which a final investment decision has been taken and that are due to be commissioned by the end of year n + 5 .


### member states may lay down conditions for exemption from the provisions of paragraph 6 when : ### member states shall lay down conditions for exemption from the provisions of paragraph 6 when :


### to the extent necessary for an understanding of the company ' s development , performance or position , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business . ### to the extent necessary for an understanding of the company ' s development , performance or position and impact on society , environment and human rights , and for the transparency and comparability of the review , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business .


### member states shall transmit the data collected according to this article to the commission . they shall also ensure that a consolidated review of these statistical reports is published . ### member states shall transmit the data collected according to this article to the commission . they shall also ensure that a consolidated review of these statistical reports is submitted to the european parliament and published .


### when drawing up the coordinated package of active labour market policy measures , member states should favour measures that will significantly contribute to the employability of the redundant workers . member states should strive towards the reintegration into employment or new activities of at least 50 % of the targeted workers within 12 months of the date of application . ### when drawing up the coordinated package of active labour market policy measures , member states should favour measures that will significantly contribute to the employability of the redundant workers . member states should strive towards the reintegration into employment or new activities of at least all of the targeted workers within 12 months of the date of application .


### ‘ a worker’ means owner - managers of micro , small and medium - sized enterprises and self - employed workers and all members of the household active in the business , provided that , if farmers , they were already producing the output affected by the relevant trade agreement before the measures concerning the specific sector were implemented . ### ‘ a worker’ means owner - managers of micro and small - sized enterprise , self - employed workers and all members of the household active in the business .


### liquidation of a failing institution under normal insolvency proceedings could jeopardise financial stability , interrupt the provision of essential services , and affect the protection of depositors . in such a case there is a public interest in applying resolution tools . the objectives of resolution should therefore be to ensure the continuity of essential financial services , to maintain the stability of the financial system , to reduce moral hazard by minimising reliance on public financial support to failing institutions , and to protect depositors . ### liquidation of a failing institution under normal insolvency proceedings could jeopardise financial stability , interrupt the provision of essential services , and affect the protection of depositors . in such a case there is a public interest in applying resolution tools . the objectives of resolution should therefore be to ensure the continuity of essential financial services , to maintain the stability of the financial system , to reduce moral hazard by minimising reliance on public financial support to failing institutions , to protect depositors and to contribute to sustainable and balanced economic growth .


### the maternity leave stipulated in paragraph 1 shall include compulsory leave of at least six weeks after childbirth . the member states shall take the necessary measures to ensure that workers within the meaning of article 2 are entitled to choose freely the time at which the non - compulsory portion of the maternity leave is taken , before or after childbirth . ### the maternity leave stipulated in paragraph 1 shall include compulsory leave on full pay of at least sixteen weeks after childbirth . the member states shall take the necessary measures to ensure that workers within the meaning of article 2 are entitled to choose freely the time at which the non - compulsory portion of the maternity leave is taken , before or after childbirth . the compulsory period of sixteen weeks shall apply to all workers , irrespective of the number of days previously worked .


### for the purposes of preventing and combating crime falling under its objectives , it is necessary for europol to have the fullest and most up - to - date information possible . therefore , europol should be able to process data provided to it by member states , third countries , international organisations and union bodies as well as coming from publicly available sources to develop an understanding of criminal phenomena and trends , to gather information about criminal networks , and to detect links between different offences . ### for the purposes of preventing and combating crime falling under its objectives , it is necessary for europol to have the fullest and most up - to - date information possible . therefore , europol should be able to process data provided to it by member states , third countries , international organisations and union bodies as well as coming from publicly available sources , as long as europol can be considered to be lawful recipient of that data , to develop an understanding of criminal phenomena and trends , to gather information about criminal networks , and to detect links between different offences .


### data protection rules at europol should be strengthened and draw on the principles underpinning regulation no 45 / 200132 to ensure a high level of protection of individuals with regard to processing of personal data . as declaration 21 attached to the treaty recognizes the specificity of personal data processing in the law enforcement context , the data protection rules of europol should be autonomous and aligned with other relevant data protection instruments applicable in the area of police cooperation in the union , in particular convention no . 10833 and recommendation no r of the council of europe34 and council framework decision 2008 / 977 / jha on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters35 [ to be replaced by the relevant directive in force at the moment of adoption ] . ### data protection rules at europol should be strengthened and aligned with other relevant data protection instruments applicable to processing of personal data in the area of police cooperation in the european union to ensure a high level of protection of individuals with regard to processing of personal data . while decision 2009 / 371 / jha provides for an adequate data protection regime for europol , it should be further elaborated to align europol with the requirements of the lisbon treaty , reflect the growing role of europol and improve the rights of data subjects . data protection rules at europol should be strengthened and draw on the principles underpinning regulation no 45 / 200132 to ensure a high level of protection of individuals with regard to processing of personal data , as well as on other data protection principles , including accountability principle , data protection impact assessment , privacy by design and by default and notification of personal data breaches . as soon as the new data protection framework of the eu institutions and bodies will be adopted , it should be applicable to europol . as declaration 21 attached to the treaty acknowledges , the specific nature of the processing of personal data in the law enforcement context proves necessary that specific rules on the protection of personal data and the free movement of such data are established for europol based on article 16 of the treaty on the functioning of the european union and aligned with other relevant data protection instruments applicable in the area of police cooperation in the union , in particular convention no . 10833 and its additional protocol of 8 november 2001 and recommendation no r of the council of europe34 and council framework decision 2008 / 977 / jha on the protection of personal data processed in the framework of police and judicial cooperation in criminal matters35 [ to be replaced by the relevant directive in force at the moment of adoption ] . transparency is a crucial part of data protection since it enables other data protection principles and rights to be exercised . to enhance transparency , europol should have transparent data protection policies that it should make easily publicly available setting out in an intelligible form and using clear and plain language the provisions regarding the processing of personal data and the means available for the exercise of the rights of data subjects , as well as publish a list of the international and cooperation agreements it has with third countries , union bodies and international organisations .


### national competent authorities for the supervision of the processing of personal data should monitor the lawfulness of the processing of personal data by member states . the european data protection supervisor should monitor the lawfulness of data processing by europol exercising its functions with complete independence . ### national competent authorities for the supervision of the processing of personal data should monitor the lawfulness of the processing of personal data by member states . an independent joint supervisory body should monitor the lawfulness of data processing by europol exercising its functions with complete independence .


### as europol is processing also non - operational personal data , not related to any criminal investigations , processing of such data should be subject to regulation no 45 / 2001 . ### as europol is processing also non - operational personal data , not related to any criminal investigations , such as personal data of staff of europol , services providers or visitors , processing of such data should be subject to regulation no 45 / 2001 .


### a european union agency for law enforcement cooperation and training is hereby established to improve mutual cooperation among law enforcement authorities in the european union , to strengthen and support their actions as well as to deliver a coherent european training policy . ### a european union agency for law enforcement cooperation is hereby established to improve mutual cooperation among the competent law enforcement authorities of the member states and to strengthen and support their actions .


### ‘ analysis’ means the assembly , processing or use of data with the aim of assisting criminal investigations ; ### ' analysis ' means the careful examination of gathered information with the aim of assisting criminal investigations ;


### ' personal data ' means any information relating to an identified or identifiable natural person hereinafter referred to as ' data subject ' ; an identifiable person is one who can be identified , directly or indirectly , in particular by reference to an identification number or to one or more factors specific to his / her physical , physiological , mental , economic , cultural or social identity ; ### ' personal data ' means any information relating to an identified or identifiable natural person ; an identifiable person is one who can be identified , directly or indirectly , in particular by reference to an identifier such as a name , an identification number , location data , unique identifier or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural or social or gender identity of that person ;


### ‘ recipient’ means a natural or legal person , public authority , agency or any other body to whom data are disclosed , whether a third party or not ; however , authorities which may receive data in the framework of a particular inquiry shall not be regarded as recipients ; ### ' recipient ' means a natural or legal person , public authority , agency or any other body to which the personal data are disclosed


### ‘ the data subject ' s consent’ means any freely given specific and informed indication of his / her wishes by which the data subject signifies his / her agreement to personal data relating to him / her being processed ; ### ' the data subject ' s consent ' means any freely given specific , informed and explicit indication of his or her wishes by which the data subject , either by a statement or by a clear affirmative action , signifies agreement to personal data relating to them being processed ;


### to notify the member states without delay of information concerning them and of any connections between criminal offences ; ### to notify the competent authorities of the member states without delay via their national units , as referred to in article 7 , of information concerning them and of any connections between criminal offences ;


### to provide technical and financial support to member states ' cross - border operations and investigations , including joint investigative teams ; ### to provide technical and financial support to member states ' cross - border operations and investigations , including through joint investigative teams where such has been agreed upon by the member states in accordance with article 5 ;


### liaison officers shall assist in the exchange of information between their member states and the liaison officers of other member states in accordance with national law . europol ' s infrastructure may be used , in line with national law , for such bilateral exchanges also to cover crimes outside the objectives of europol . the management board shall determine the rights and obligations of liaison officers in relation to europol . ### liaison officers shall assist in the exchange of information between their member states and the liaison officers of other member states in accordance with national law . europol ' s infrastructure may be used , in line with national law , for such bilateral exchanges also to cover crimes outside the objectives of europol . the management board shall determine the rights and obligations of liaison officers in relation to europol . all such exchanges of information shall be in accordance with union and national law , in particular the council framework decision 2008 / 977 / jha or directive 95 / 46 / ec , as applicable . europol shall process data received under this provision only when it can be considered a lawful recipient under national or union law .


### the management board shall adopt the annual work programme the latest by 30 november each year , based on a draft put forward by the executive director , taking into account the opinion of the commission . it shall forward it to the european parliament , the council , the commission and national parliaments . ### the management board shall adopt , in agreement with the parliamentary scrutiny unit , the annual work programme the latest by 30 november each year , based on a draft put forward by the executive director , taking into account the opinion of the commission . it shall forward the draft work programme to the european parliament , the council , the commission and national parliaments at least three months prior to adoption .


### cross - checking aimed at identifying connections between information ; ### cross - checking solely aimed at identifying possible connections between data provided by a member state and data already processed by europol ;


### a member state , a union body , a third country or an international organisation providing information to europol determines the purpose for which it shall be processed as referred to in article 24 . if it has not done so , europol shall determine relevance of such information as well as the purpose for which it shall be processed . europol may process information for a different purpose than the one for which information has been provided only if authorised by the data provider . ### a member state , a union body , a third country or an international organisation providing information to europol determines the purpose for which it shall be processed as referred to in article 24 . europol may process information for a different purpose than the one for which information has been provided only if authorised by the data provider . such purposes shall be explicit and tailored as narrowly as possible , in accordance with the data protection principles as laid down in directive 95 / 46 / ec and council framework decision 2008 / 977 / jha . .