### experience has shown that cultivation of gmos is an issue which is more thoroughly addressed by member states , either at central or at regional and local level . contrary to issues related to the placing on the market and the import of gmos , which should remain regulated at eu level to preserve the internal market , cultivation has been acknowledged as an issue with a strong local / regional dimension . in accordance with article 2 tfeu member states should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of gmos in their territory after the gmo has been legally authorised to be placed on the eu market . ### experience has shown that cultivation of gmos is an issue which is more thoroughly addressed by member states , either at central or at regional and local level . issues related to the placing on the market and the import of gmos should remain regulated at union level to preserve the internal market . cultivation might require more flexibility in certain instances as it is an issue with a strong local / regional dimension . however , the common authorisation procedure should not be adversely affected by such flexibility . in accordance with article 2 tfeu member states should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of gmos in their territory after the gmo has been legally authorised to be placed on the union market , provided that those rules do not adversely affect the free movement and marketing of gmo products and seeds .


### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation . ### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the union cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of gmos on a case - by - case basis in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of union rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products , the principle of proportionality and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation . those measures should also ensure that the freedom of choice of farmers and consumers is duly respected . to achieve that goal , appropriate seed thresholds for labelling gmo traces in conventional seeds should be put in place as a matter of priority . the necessity of such measures was also emphasised in the council conclusions of 4 december 2008 on gmos .


### in directive 2001 / 18 / ec , the following article shall be inserted with effect from the date of entry into force of this regulation : ### the following articles shall be inserted with effect from the date of entry into force of this regulation :


### member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos authorised in accordance with part c of this directive or regulation no 1829 / 2003 , and consisting of genetically modified varieties placed on the market in accordance with relevant eu legislation on the marketing of seed and plant propagating material , in all or part of their territory , provided that : ### member states may adopt measures restricting or prohibiting the cultivation of gmos authorised in accordance with part c of this directive or regulation no 1829 / 2003 , and consisting of genetically modified varieties placed on the market in accordance with relevant eu legislation on the marketing of seed and plant propagating material , on a case - by - case basis , in all their territory , provided that :


### that they are in conformity with the treaties . ### that those measures are in conformity with the treaties , in particular with the principle of proportionality and the union ' s international obligations .


### that they are in conformity with the treaties . ### that those measures are in conformity with the treaties and the union ' s international obligations .


### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning : ### the commission shall , after the consultation of the edps , be empowered to adopt delegated acts in accordance with article 15a concerning :


### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning the requirements and conditions for operators to provide information as referred to in paragraph 2 . ### the commission shall , after consultation of the edps , be empowered to adopt delegated acts in accordance with article 15a concerning the requirements and conditions for operators to provide information as referred to in paragraph 2 .


### the commission shall be empowered to adopt delegated acts in accordance with article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations granted to nicotine - containing products pursuant to directive 2001 / 83 / ec . ### the commission shall , by 1 april 2017 , carry out a study on nicotine - containing products in consultation with relevant stakeholders and the member states . this study will consider whether there is a need for specific legislation in regard to nicotine - containing products .


### nicotine containing products below the threshold set out in article 18 ; ### nicotine containing products ;


### because of the pace of technological change , this regulation should adopt an approach which is open to innovations . ### because of the pace of technological change , this regulation should adopt an approach which is open to innovations but which focuses at all times primarily on consumers and their interests .


### to enhance people ' s trust in the internal market and to promote the use of trust services and products , the notions of qualified trust services and qualified trust service provider should be introduced with a view to indicating requirements and obligations to ensure high - level security of whatever qualified trust services and products are used or provided . ### to enhance people ' s trust in the internal market and to promote the use of trust services and products , the notions of qualified trust services and qualified trust service provider should be introduced with a view to indicating requirements and obligations to ensure high - level security of whatever qualified trust services and products are used or provided . both qualified and advanced electronic signatures may be legally equivalent to handwritten signatures . nothing in this regulation should limit the ability of any natural or legal person to demonstrate with evidence the non - reliability of any form of electronic signature . however , in the case of a qualified electronic signature the burden of proof when questioning the identity of the signatory should rest with the contesting party .


### in line with the obligations under the un convention on the rights of persons with disabilities that has entered into force in the eu , persons with disabilities should be able to use trust services and end user products used in the provision of those services on equal bases with other consumers . ### in line with the obligations under the un convention on the rights of persons with disabilities that has entered into force in the eu and in line the commission proposal on the accessibility of public sector bodies ' websites1 , persons with disabilities should be able to use trust services and end user products used in the provision of those services on equal bases with other consumers . __________________ 1proposal for a directive of the european parliament and of the council on the accessibility of public sector bodies ' websites . 0721 ) .


### this regulation ensures that trust services and products which comply with this regulation are permitted to circulate freely in the internal market . ### this regulation ensures that qualified and non - qualified trust services and products which comply with this regulation are permitted to circulate freely in the internal market .


### ‘ trust service’ means any electronic service consisting in the creation , verification , validation , handling and preservation of electronic signatures , electronic seals , electronic time stamps , electronic documents , electronic delivery services , website authentication , and electronic certificates , including certificates for electronic signature and for electronic seals ; ### ‘ trust service’ means any electronic service consisting in the creation , verification , validation , handling and preservation of electronic signatures , electronic seals , electronic time stamps , electronic documents , electronic delivery services , or electronic certificates , including certificates for electronic signature and for electronic seals ;


### ‘ trust service’ means any electronic service consisting in the creation , verification , validation , handling and preservation of electronic signatures , electronic seals , electronic time stamps , electronic documents , electronic delivery services , website authentication , and electronic certificates , including certificates for electronic signature and for electronic seals ; ### ‘ trust service’ means any electronic service consisting , among others , of the creation , verification , validation , handling and preservation of electronic signatures , electronic seals , electronic time stamps , electronic documents , electronic delivery services , website authentication , and electronic certificates , including certificates for electronic signature and for electronic seals ;


### ‘ creator of a seal’ means a legal person who creates an electronic seal ; ### ‘ creator of a seal’ means an entity or a legal or natural person who creates an electronic seal ;


### when an electronic identification using an electronic identification means and authentication is required under national legislation or administrative practice to access a service online , any electronic identification means issued in another member state falling under a scheme included in the list published by the commission pursuant to the procedure referred to in article 7 shall be recognised and accepted for the purposes of accessing this service . ### when an electronic identification using an electronic identification means and authentication is required under national legislation or administrative practice to access a service online , electronic identification means of the same or higher security assurance level issued in another member state , notified pursuant to the procedure referred to in article 7 , shall be recognised for the purposes of accessing this service online 6 months following the publishing of the list of notified schemes by the commission .


### the notifying member state ensures that the person identification data are attributed unambiguously to the natural or legal person referred to in article 3 point 1 ; ### the notifying member state ensures that the person identification data are attributed to the natural or legal person referred to in article 3 point 1 either unambiguously or to the degree necessary for the specific purpose ;


### a description of the notified electronic identification scheme ; ### description of the notified electronic identification scheme , including the level of security ;


### coordination ### interoperability and coordination


### the commission shall , by means of implementing acts , establish the necessary modalities to facilitate the cooperation between the member states referred to in paragraph 1 with a view to fostering a high level of trust and security appropriate to the degree of risk . those implementing acts shall concern , in particular , the exchange of information , experiences and good practice on electronic identification schemes , the peer review of notified electronic identification schemes and the examination of relevant developments arising in the electronic identification sector by the competent authorities of the member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission shall , by means of implementing acts , establish the interoperability framework to facilitate the cooperation between the member states referred to in paragraph 1 with a view to fostering a high level of trust and security appropriate to the degree of risk . those implementing acts shall concern , in particular , the exchange of information , experiences and good practice on electronic identification schemes , the peer review of notified electronic identification schemes and the examination of relevant developments arising in the electronic identification sector by the competent authorities of the member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue . ### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if : the qualified trust service provider fulfils the requirements laid down in this regulation and has been accredited under a voluntary accreditation scheme established in a member state ; or a qualified trust service provider established within the union which fulfils the requirements laid down in this regulation guarantees the compliance with the requirements of this regulation ; or the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue .


### the commission may , by means of implementing acts , define the circumstances , formats and procedures for the report referred to in paragraph 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the formats and procedures for the report referred to in paragraph 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### the commission may , by means of implementing acts , define the circumstances , formats and procedures , including deadlines , applicable for the purpose of paragraphs 1 to 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the further specification of the measures referred to in paragraph 1 and formats and procedures , including deadlines , applicable for the purpose of paragraphs 1 to 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### the commission may , by means of implementing acts , define the circumstances , procedures and formats applicable for the purpose of paragraphs 1 , 2 and 4 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the procedures and formats applicable for the purpose of paragraphs 1 , 2 and 4 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### the commission may , by means of implementing acts , define the circumstances , formats and procedures for the purpose of paragraphs 1 , 2 and . 3 those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the formats and procedures for the purpose of paragraphs 1 , 2 and . 3 those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### a supervisory body to which a request for assistance is addressed may not refuse to comply with it unless : ### a supervisory body may refuse a request for assistance if :


### compliance with the request would be incompatible with this regulation . ### compliance with the request would go beyond the tasks and powers of the supervisory body set out in this regulation .


### without prejudice to article 16 , any trust service provider may submit the report of a security audit carried out by a recognised independent body to the supervisory body to confirm that appropriate security measures have been taken . ### without prejudice to article 16 , any trust service provider shall , without undue delay and not later than 6 months following the commencement of its activities , submit the report of a compliance audit carried out by a recognised independent body to the supervisory body to confirm that appropriate security measures have been taken .


### trust service providers shall , without undue delay and where feasible not later than 24 hours after having become aware of it , notify the competent supervisory body , the competent national body for information security and other relevant third parties such as data protection authorities of any breach of security or loss of integrity that has a significant impact on the trust service provided and on the personal data maintained therein . ### trust service providers shall , without undue delay after having become aware of it , notify the competent supervisory body and , where appropriate , the competent national body for information security and other relevant third parties such as data protection authorities of any breach of security or loss of integrity that has a significant impact on the trust service provided .


### without prejudice to article 16 , any trust service provider may submit the report of a security audit carried out by a recognised independent body to the supervisory body to confirm that appropriate security measures have been taken . ### without prejudice to article 16 , any trust service provider shall submit the report of a security audit carried out by a recognised independent body to the supervisory body after an incident to confirm that appropriate security measures have been taken .


### qualified trust service providers shall be audited by a recognised independent body once a year to confirm that they and the qualified trust services provided by them fulfil the requirements set out in this regulation , and shall submit the resulting security audit report to the supervisory body . ### qualified trust service providers shall , at their own expense , be audited by a recognised independent body every second year to confirm that they and the qualified trust services provided by them fulfil the requirements set out in this regulation , and shall submit the resulting security audit report to the competent supervisory body .


### the commission may , by means of implementing acts , establish reference numbers of standards for trustworthy systems and products . compliance with the requirements laid down in article 19 shall be presumed where trustworthy systems and products meet those standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union . ### the commission may , by means of implementing acts , establish reference numbers of standards for systems and products , for which compliance with the requirements laid down in article 19 shall be presumed . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union .


### when issuing a qualified certificate , a qualified trust service provider shall verify , by appropriate means and in accordance with national law , the identity and , if applicable , any specific attributes of the natural or legal person to whom a qualified certificate is issued . ### when issuing a qualified certificate , a qualified trust service provider shall verify , by appropriate means and in accordance with national law , the identity and , if applicable , any specific attributes of the entity , natural or legal person to whom a qualified certificate is issued .


### if an electronic seal security assurance level below the qualified electronic seal is required , in particular by a member state for accessing a service online offered by a public sector body on the basis of an appropriate assessment of the risks involved in such a service , all electronic seals matching at a minimum the same security assurance level shall be accepted . ### if an electronic seal security assurance level below the qualified electronic seal is required by a member state for accessing a service online offered by a public sector body on the basis of an appropriate assessment of the risks involved in such a service , all electronic seals matching at a minimum the same security assurance level shall be accepted .


### the commission may , by means of implementing acts , establish reference numbers of standards for the security assurance levels of electronic seals . compliance with the security assurance level defined in a delegated act adopted pursuant to paragraph 6 shall be presumed when an electronic seal meets those standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union . ### the commission may , by means of implementing acts , define different security assurance levels of electronic seals referred to in paragraph 4 and establish reference numbers of standards for the security assurance levels of electronic seals . compliance with the security assurance level defined in a delegated act adopted pursuant to paragraph 6 shall be presumed when an electronic seal meets those standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union .


### the commission may , by means of implementing acts , establish reference numbers of standards for the security assurance levels of electronic seals . compliance with the security assurance level defined in a delegated act adopted pursuant to paragraph 6 shall be presumed when an electronic seal meets those standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union . ### the commission shall , by means of implementing acts , establish reference numbers of standards for the defined security levels of electronic seals . compliance with the defined security level in annex iii shall be presumed when an electronic seal meets those standards . the implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union .


### the commission may , by means of implementing acts , establish reference numbers of standards for qualified certificates for electronic signature . compliance with the requirements laid down in annex i shall be presumed where a qualified certificate for electronic signature meets those standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union . ### the commission may , by means of implementing acts , specify the requirements laid down in annex i and establish reference numbers of standards for qualified certificates for electronic signature . compliance with the requirements laid down in annex i shall be presumed where a qualified certificate for electronic signature meets those standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union .


### a document bearing a qualified electronic signature or a qualified electronic seal of the person who is competent to issue the relevant document , shall enjoy legal presumption of its authenticity and integrity provided the document does not contain any dynamic features capable of automatically changing the document . ### a document bearing a qualified electronic signature or a qualified electronic seal of the person who is competent to issue the relevant document , shall enjoy legal presumption of its authenticity and integrity provided the document does not contain any dynamic features capable of automatically changing the content of the document subsequently .


### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article . 2 . the power to adopt delegated acts referred to in articles 8 , 13 , 15 , 16 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 29 , 30 , 31 , 35 and 37 shall be conferred on the commission for an indeterminate period of time from the entry into force of this regulation . 3 . the delegation of power referred to in articles 8 , 13 , 15 , 16 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 28 , 29 , 30 , 31 , 35 and 37 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . a delegated act adopted pursuant to articles 8 , 13 , 15 , , 16 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 29 , 30 , 31 , 35 and 37 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article . 2 . the power to adopt delegated acts referred to in articles 8a , 15 , 16 , 21 , 23 , 25 , 27 , 29 , 30 , 31 , 35 and 37 shall be conferred on the commission for an indeterminate period of time from the entry into force of this regulation . 3 . the delegation of power referred to in articles 8a , 15 , 16 , 21 , 23 , 25 , 27 , 29 , 30 , 31 , 35 and 37 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . a delegated act adopted pursuant to articles 8a , 15 , 16 , 21 , 23 , 25 , 27 , 29 , 30 , 31 , 35 and 37 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### draft by the court of justice ### the second paragraph of article 23 shall be replaced by the following : ' within ten weeks of this notification , the parties , the member states , the commission and , where appropriate , the institution , body , office or agency which adopted the act the validity or interpretation of which is in dispute , shall be entitled to submit statements of case or written observations to the court . '


### draft by the court of justice ### the first paragraph of article 47 shall be replaced by the following : ' the first paragraph of article 9a , articles 14 and 15 , the first , second , fourth and fifth paragraphs of article 17 and article 18 shall apply to the general court and its members . '


### draft by the court of justice ### the following article shall be inserted : ' article 48a the vice - president shall assist the president of the court . he shall take the latter’s place when he is prevented from attending or when the office of president is vacant . he shall also take his place for the purposes of discharging the responsibilities set out in article 39 in accordance with the conditions laid down in the rules of procedure . '


### draft by the court of justice ### the following paragraph shall be inserted after the first paragraph of article 50 : ' where a large volume of litigation exists in relation to a given subject or subjects , the general court may provide for the establishment of an appropriate number of specialised chambers to which cases in that regard are to be assigned . '


### draft by the court of justice ### the first paragraph of article 56 shall be replaced by the following : ' an appeal may be brought before the court of justice , within ten weeks of the notification of the decision appealed against , against final decisions of the general court and decisions of that court disposing of the substantive issues in part only or disposing of a procedural issue concerning a plea of lack of competence or inadmissibility . '


### draft by the court of justice ### the first paragraph of article 57 shall be replaced by the following : ' any person whose application to intervene has been dismissed by the general court may appeal to the court of justice within three weeks from the notification of the decision dismissing the application . '


### draft by the court of justice ### the first paragraph of article 9 of annex i shall be replaced by the following : ' an appeal may be brought before the general court , within ten weeks of notification of the decision appealed against , against final decisions of the civil service tribunal and decisions of that tribunal disposing of the substantive issues in part only or disposing of a procedural issue concerning a plea of lack of jurisdiction or inadmissibility . '


### draft by the court of justice ### article 10 of annex i shall be replaced by the following : ' 1 . any person whose application to intervene has been dismissed by the civil service tribunal may appeal to the general court within three weeks of notification of the decision dismissing the application . '


### specific measures and objectives for the freshwater part of the life cycle of anadromous and catadromous species ; ### specific measures and objectives for the freshwater part of the life cycle of anadromous and catadromous species ; specific measures to define sustainable fishing of anadromous species on a stock - by - stock basis ;


### advisory councils shall be composed of organisations representing the fisheries operators and other interest groups affected by the common fisheries policy . ### advisory councils shall be composed of organisations representing the fisheries operators , interest groups for river banks and other interest groups affected by the common fisheries policy .


### the commission has committed to mainstream climate change into union spending programmes and to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that climate change mitigation and adaptation as well as risk prevention and management are promoted in the preparation , design and implementation of projects of common interest . infrastructure investments covered by this regulation should contribute to promoting the transition to a low - carbon and climate - and disaster - resilient economy and society . ### the commission has committed to mainstream climate change into union spending programmes and to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that climate change mitigation and adaptation as well as risk prevention and management are promoted in the preparation , design and implementation of projects of common interest . infrastructure investments covered by this regulation should contribute to promoting the transition to a low - carbon and climate - and disaster - resilient economy and society . the commission should ensure that international agreements and standards applicable within the internal market are applied even - handedly to the member states , without causing distortions of competition , in order to ensure the success of european undertakings in the face of global competition .


### based on an analysis of the transport infrastructure plans of member states , the commission estimates that investment needs in transport amount to eur 500 billion in the entirety of the ten - t network for the period 2014 - 2020 , of which an estimated eur 250 billion will need to be invested in the core network of the ten - t . given the resources available at union level , concentration on the projects with the highest european added value is necessary to achieve the desired impact . support should therefore be focussed on the core network and on the projects of common interest in the field of traffic management systems . ### based on an analysis of the transport infrastructure plans of member states , the commission estimates that investment needs in transport amount to eur 500 billion in the entirety of the ten - t network for the period 2014 - 2020 , of which an estimated eur 250 billion will need to be invested in the core network of the ten - t . given the resources available at union level , concentration on the projects with the highest european added value is necessary to achieve the desired impact . support should therefore be focussed on the core network and on the projects of common interest in the field of traffic management systems . sufficient eu funding must be earmarked for projects for a comprehensive network , because such a network is the most effective way of supporting the union’s objectives with regard to increasing social and territorial cohesion and improving access to the regions throughout the union’s territory .


### multi - annual programming for support from the facility should be directed towards supporting the union ' s priorities by ensuring the availability of the necessary financial resources and the consistency and continuity of joint action by the union and the member states . for proposals submitted following the implementation of the first multiannual work programme in the sector of transport , eligibility of cost should start on 1 january 2014 to ensure the continuity of projects already covered by regulation no 680 / 2007 of the european parliament and of the council of 20 june 2007 laying down general rules for the granting of community financial aid in the field of the trans - european transport and energy networks . ### multi - annual programming for support from the facility should be directed towards supporting the union ' s priorities by ensuring the availability of the necessary financial resources and the consistency , fairness and continuity of joint action by the union and the member states . for proposals submitted following the implementation of the first multiannual work programme in the sector of transport , eligibility of cost should start on 1 january 2014 to ensure the continuity of projects already covered by regulation no 680 / 2007 of the european parliament and of the council of 20 june 2007 laying down general rules for the granting of community financial aid in the field of the trans - european transport and energy networks .


### contribute to smart , sustainable and inclusive growth by developing modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation . ### contribute to smart , sustainable and inclusive growth by developing modern and high performing trans - european networks which take account of future traffic flows , thus bringing forward benefits for the entire european union in terms of competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation .


### contributing to sustainable development and protection of the environment , notably by fostering the integration of energy from renewable sources into the transmission network and developing carbon dioxide networks , to be measured by the transmission of renewable energy from generation to major consumption centers and storage sites , and the sum of co2 emissions prevented by the construction of the projects which benefited from cef . ### contributing to sustainable development and protection of the environment , notably by fostering the integration of energy from renewable sources into the transmission network , developing carbon dioxide networks and investing in sustainable transport , to be measured by the transmission of renewable energy from generation to major consumption centers and storage sites , and the sum of co2 emissions prevented by the construction of the projects which benefited from cef .


### every natural person should have the right not to be subject to a measure which is based solely on automated processing if it produces an adverse legal effect for that person , unless authorised by law and subject to suitable measures to safeguard the data subject ' s legitimate interests . ### every natural person should have the right not to be subject to a measure which is based partially or fully on automated processing if it produces an adverse legal effect for that person or significantly affects that person , unless authorised by law and subject to suitable measures to safeguard the data subject ' s legitimate interests .


### any person should have the right of access to data which has been collected concerning them , and to exercise this right easily , in order to be aware of and verify the lawfulness of the processing . every data subject should therefore have the right to know about and obtain communication in particular of the purposes for which the data are processed , for what period , which recipients receive the data , including in third countries data subjects should be allowed to receive a copy of their personal data which are being processed . ### any person should have the right of access to data which has been collected concerning them , and to exercise this right easily , in order to be aware of and verify the lawfulness of the processing . every data subject should therefore have the right , when possible in advance , to know about and obtain communication in particular of the purposes for which the data are processed , for what period , which recipients receive the data , including in third countries data subjects should be allowed to receive a copy of their personal data which are being processed .


### processed fairly and lawfully ; ### processed lawfully , fairly and in a transparent manner in relation to the data subject ;


### processed fairly and lawfully ; ### processed fairly and lawfully and in a transparent manner ;


### member states shall provide that measures which produce an adverse legal effect for the data subject or significantly affect them and which are based solely on automated processing of personal data intended to evaluate certain personal aspects relating to the data subject shall be prohibited unless authorised by a law which also lays down measures to safeguard the data subject ' s legitimate interests . ### member states shall provide that every data subject has the right not to be subject to a measure which produces a legal effect concerning this natural person , or significantly affects this natural person , and which is based on partially or fully automated processing of personal data intended to evaluate certain personal aspects relating to this natural person .


### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are vexatious , in particular because of their repetitive character , or the size or volume of the request , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the vexatious character of the request . ### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge and in written form . where requests are vexatious , in particular because of their repetitive character , or the size or volume of the request , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the vexatious character of the request .


### in cases referred to in paragraphs 1 and 2 , member states shall provide that the controller informs the data subject in writing on any refusal or restriction of access , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy . the information on factual or legal reasons on which the decision is based may be omitted where the provision of such information would undermine a purpose under paragraph 1 . ### in cases referred to in paragraphs 1 and 2 , member states shall provide that the controller informs the data subject with undue delay in writing on any refusal or restriction of access , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy . the information on factual or legal reasons on which the decision is based may be omitted where the provision of such information would undermine a purpose under paragraph 1 .


### member states shall provide for the right of the data subject to obtain from the controller the rectification of personal data relating to them which are inaccurate . the data subject shall have the right to obtain completion of incomplete personal data , in particular by way of a corrective statement . ### member states shall provide for the right of the data subject to obtain from the controller the rectification or completion of personal data relating to them which are inaccurate or incomplete . the data subject shall have the right to obtain rectification or completion of inaccurate or incomplete personal data , in particular by way of a corrective or completing statement .


### member states shall provide for the right of the data subject to obtain from the controller the erasure of personal data relating to them where the processing does not comply with the provisions adopted pursuant to articles 4 to , 7 and 8 of this directive . ### member states shall provide for the right of the data subject to obtain from the controller the erasure of personal data relating to them and the abstention from further dissemination of such data where the processing does not comply with the provisions adopted pursuant to articles 4 to , 7 and 8 of this directive .


### member states shall provide for the right of the data subject to obtain from the controller the erasure of personal data relating to them where the processing does not comply with the provisions adopted pursuant to articles 4 to , 7 and 8 of this directive . ### member states shall provide for the right of the data subject to obtain from the controller the erasure and abstention of further processing of personal data relating to them where the processing does not comply with the provisions adopted pursuant to articles 4 to , 7 and 8 of this directive . the controller should take all reasonable steps , including technical measures , to inform third parties .


### member states shall provide that , having regard to the state of the art and the cost of implementation , the controller shall implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject . ### member states shall provide that , having regard to the state of the art and the cost of implementation , the controller shall implement , both at the time of the determination of the means for processing and at the time of the processing itself , appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject .


### member states shall provide that where a processing operation is carried out on behalf of a controller , the controller must choose a processor providing sufficient guarantees to implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of the provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject . ### member states shall provide that where a processing operation is carried out on behalf of a controller , the controller shall choose a processor providing sufficient guarantees to implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of the provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject , in particular in respect of the technical security measures and organizational measures governing the processing to be carried out and to ensure compliance with those measures .


### member states shall provide that the carrying out of processing by a processor must be governed by a legal act binding the processor to the controller and stipulating in particular that the processor shall act only on instructions from the controller , in particular , where the transfer of the personal data used is prohibited . ### member states shall provide that the carrying out of processing by a processor must be governed by a legal act binding the processor to the controller and stipulating in particular that the processor shall : act only on instructions from the controllers ; employ only staff who have agreed to be bound by an obligation of confidentiality or are under a statutory obligation of confidentiality ; take all required measures pursuant to article 28 ; engage another processor only with the permission of the controller and therefore inform the controller of the intention to engage another processor in such a timely fashion that the controller has the possibility to object ; insofar as it is possible given the nature of the processing , adopt in agreement with controller the necessary technical and organisational requirements for the fulfilment of the controller ' s obligation to respond to requests for exercising the data subject ' s rights laid down in chapter iii ; assist the controller in ensuring compliance with the obligations pursuant to articles 28 to 32 ; hand all results over to the controller after the end of the processing and not otherwise process the personal data ; make available to the controller and the supervisory authority all the information necessary to verify compliance with the obligations laid down in this article ; take into account the principle of data protection by design and default .


### member states may provide that the supervisory authority establishes a list of the processing operations which are subject to prior consultation pursuant to paragraph 1 . ### member states may provide that the supervisory authority shall establish a list of the processing operations which are subject to prior consultation pursuant to point of paragraph 1 . the supervisory authority shall publicly communicate that list and forward it to the european data protection board . the european data protection board shall work on the convergence of those lists .


### member states shall provide that the controller documents any personal data breaches , comprising the facts surrounding the breach , its effects and the remedial action taken . this documentation must enable the supervisory authority to verify compliance with this article . the documentation shall only include the information necessary for that purpose . ### member states shall provide that the controller documents any personal data breaches , comprising the facts surrounding the breach , its effects and the remedial action taken . this documentation must enable the supervisory authority to verify compliance with this article . the documentation shall only include the information necessary for that purpose . the supervisory authority shall keep a public record of the breaches notified .


### the commission may lay down the standard format of such notification to the supervisory authority , the procedures applicable to the notification requirement and the form and the modalities for the documentation referred to in paragraph 4 , including the time limits for erasure of the information contained therein . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 57 . ### the commission , after consultation of the european data protection authority , may lay down the standard format of such notification to the supervisory authority , the procedures applicable to the notification requirement and the form and the modalities for the documentation referred to in paragraph 4 , including the time limits for erasure of the information contained therein . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 57 .


### for each securities settlement system it operates , a csd shall establish procedures that facilitate settlement of transactions in financial instruments referred to in article 5 that are not settled on the intended settlement date . these procedures shall provide for a sufficiently deterrent penalty mechanism for participants that cause the settlement fails . ### for each securities settlement system it operates , a csd shall establish procedures that facilitate settlement of transactions in financial instruments referred to in article 5 that are not settled on the intended settlement date referred to in article 5 . these procedures shall provide for a sufficiently deterrent penalty mechanism for participants that cause the settlement fails where there is not already such a procedure provided for by a ccp in a member state under regulation 236 / 2012 / eu [ short selling ] .


### for each securities settlement system it operates , a csd shall establish procedures that facilitate settlement of transactions in financial instruments referred to in article 5 that are not settled on the intended settlement date . these procedures shall provide for a sufficiently deterrent penalty mechanism for participants that cause the settlement fails . ### for each securities settlement system it operates , a csd , in consultation with the relevant regulated markets , mtfs , otfs and ccps in respect of which it provides settlement services , shall establish procedures that facilitate settlement of transactions in financial instruments referred to in article 5 that are not settled on the intended settlement date . these procedures shall provide for a sufficiently deterrent penalty mechanism for participants , other than the ccp , that cause the settlement fails .


### a participant to a securities settlement system that fails to deliver the financial instruments referred to in article 5 to the receiving participant on the intended settlement date shall be subject to a buy - in whereby those instruments shall be bought in the market no later than four days after the intended settlement date and delivered to that receiving participant and other measures in accordance with paragraph 4 . ### a participant , other than a ccp , to a securities settlement system that fails to deliver the financial instruments referred to in article 5 to the receiving participant on the intended settlement date shall be subject to a buy - in whereby those instruments shall be bought in the market no later than four days after the intended settlement date and delivered to that receiving participant and other measures in accordance with paragraph 4 .


### it is important that ingredients used in the manufacture of the categories of food covered by this regulation are appropriate to satisfy the nutritional requirements of , and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data . such adequacy should be demonstrated through a systematic review of the available scientific data . ### it is important that ingredients used in the manufacture of the categories of food covered by this regulation are appropriate to satisfy the nutritional requirements of , and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data . such adequacy should be demonstrated through a systematic and independent review of the available scientific data .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . a clear and time - efficient procedure with due regard to consumer health protection should also be ensured to enable the foodstuff resulting from scientific and technological innovations to be placed on the market rapidly .


### adequate transitional measures are necessary to enable food business operators to adapt to the requirements of this regulation . ### adequate transitional measures as well as assistance and up - to - date information for the food business operators are necessary to enable them to adapt to the requirements of this regulation .


### the composition of food referred to in article 1 shall be such that it is appropriate to satisfy the nutritional needs of , and it is suitable for the persons to whom it is intended , in accordance with generally accepted scientific data . ### the composition of food referred to in article 1 shall be such that it is appropriate to satisfy the nutritional needs of , and it is suitable for the persons to whom it is intended , in accordance with generally accepted and independently evaluated scientific data .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 must not be misleading and shall : provide adequate consumer information ; and be based on the advice of independent persons having qualifications in medicine , nutrition or pharmacy , taking into account the specific needs of the persons for whom the food is intended .


### the member state referred to in paragraph 2 shall immediately notify other member states and the european securities and markets authority established by regulation… / …of the european parliament and of the council and shall communicate to the latter all information essential to achieve its tasks . ### the member state referred to in paragraph 2 shall immediately notify the european systemic risk board , other member states and the european securities and markets authority established by regulation… / …of the european parliament and of the council and shall communicate to the latter all information essential to achieve its tasks .


### member states shall establish a register of all investment firms . the register shall be publicly accessible and shall contain information on the services or activities for which the investment firm is authorised . it shall be updated on a regular basis . the european securities and markets authority established by regulation… / …of the european parliament and of the council shall establish a list of all investment firms in the community . the european securities and markets authority shall publish that list and shall keep it up to date . ### member states shall register all investment firms which provide services or carry out activities within their sphere of authority . a systematically updated list of those firms shall be transferred to the european securities and markets authority established by regulation… / …of the european parliament and of the council . the european supervisory authority shall establish a register of all investment firms in the union . the register shall be publicly accessible and shall contain information on the services or activities for which the investment firm is authorised . it shall be updated on a regular basis . where a competent authority has withdrawn an authorisation in accordance with article 8 to , the withdrawal shall be published in the register for a period of two years .


### if , at the end of the two month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the two month period or after a joint decision has been reached . ### if , at the end of the two month period following receipt of a request under the first subparagraph any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities of the host member state shall await the decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with eu law , and shall take their final decision in conformity with the authority ' s decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of that two month period or after a joint decision has been reached .


### where an emergency situation , including adverse developments in financial markets , arises , which potentially jeopardises the market liquidity and the stability of the financial system in any of the member state where entities of a group have been authorised or where significant branches referred to in article 42a are established , the consolidating supervisor shall , subject to chapter 1 , section 2 , alert as soon as is practicable , the european banking authority and the authorities referred to in the fourth subparagraph of article 49 and article 50 , and shall communicate all information essential for the pursuance of their tasks . those obligations shall apply to all competent authorities under articles 25 and 126 and to the competent authority identified under article 129 . ### where a potential or effective emergency situation , including any potential adverse developments in financial markets or in real economy , arises , which potentially jeopardises the market liquidity and the stability of the financial system in any of the member state where entities of a group have been authorised or where significant branches referred to in article 42a are established , the consolidating supervisor shall , subject to chapter 1 , section 2 , alert as soon as is practicable , the european banking authority , the european systemic risk board and other authorities referred to in the fourth subparagraph of article 49 and article 50 , and shall communicate all information essential for the pursuance of their tasks . those obligations shall apply to all competent authorities under articles 125 and 126 and to the competent authority identified under article 129 .


### this directive is to contribute to the proper functioning of the internal market and to the achievement of a high level of consumer protection by approximating certain aspects of the laws , regulations and administrative provisions of the member states in respect of contracts on package travel and assisted travel arrangements concluded between travellers and traders . ### this directive is to contribute to the proper functioning of the internal market and to the achievement of a high level of consumer protection by approximating certain aspects of the laws , regulations and administrative provisions of the member states in respect of contracts on package travel concluded between travellers and traders .


### where minors travel on a package that includes accommodation , information enabling direct contact with the minor or the person responsible at the minor ' s place of stay ; ### where unaccompanied minors travel on a package that includes accommodation , information enabling direct contact with the unaccompanied minor or the person responsible at the minor ' s place of stay ;


### member states shall ensure that a retailer who has agreed to arrange the booking of a package or assisted travel arrangements or who facilitates the booking of such services shall be liable for any errors occurring in the booking process , unless such errors are attributable to the traveller or to unavoidable and extraordinary circumstances . ### member states shall ensure that a retailer who has agreed to arrange the booking of a package shall be liable for any errors occurring in the booking process , unless such errors are attributable to the traveller or to unavoidable and extraordinary circumstances .


### social enterprises are a cornerstone of europe’s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises’ access to finance and thereby contribute to the social business initiative launched by the commission . ### social enterprises play a role in europe’s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises’ access to finance and thereby contribute to the social business initiative launched by the commission .


### modernise union law in line with the smart regulation principles and ensure that union law on matters relating to working conditions is effectively applied ; ### modernise union law in line with the smart regulation principles and ensure that union law on matters relating to working conditions is effectively applied , with due account being given to the division of responsibilities between legislators and the social partners ;


### in the light of advice from ices and stecf certain technical conservation measures in the west of scotland , celtic sea and irish sea to protect rockall haddock , cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks . ### in the light of advice from ices and stecf certain technical conservation measures in the west of scotland , celtic sea and irish sea , to protect cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks .


### it shall be prohibited to conduct any fishing activity for cod , haddock and whiting within that part of ices division via that lies to the east or to the south of those rhumb lines which sequentially join the following coordinates which shall be measured according to the wgs84 system : – 54o30 ' n , 10o35 ' w – 55o20 ' n , 09o50 ' w – 55o30 ' n , 09o20 ' w – 56o40 ' n , 08o55 ' w – 57o00 ' n , 09o00 ' w – 57o20 ' n , 09o20 ' w – 57o50 ' n , 09o20 ' w – 58o10 ' n , 09o00 ' w – 58o40 ' n , 07o40 ' w – 59o00 ' n , 07o30 ' w – 59o20 ' n , 06o30 ' w – 59o40 ' n , 06o05 ' w – 59o40 ' n , 05o30 ' w – 60o00 ' n , 04o50 ' w – 60o15 ' n , 04o00 ' w ### it shall be prohibited to conduct any fishing activity for cod and whiting within that part of ices division via that lies within the following area which consists of the following ices statistical rectangles or any part thereof : – 54o30 ' n 10o00 ' w – 55o00 ' n 10o00 ' w – 55o00 ' n 09o00 ' w – 58o00 ' n 09o00 ' w – 58o00 ' n 08o00 ' w – 58o30 ' n 08o00 ' w – 58o30 ' n 07o00 ' w – 59o00 ' n 07o00 ' w – 59o00 ' n 06o00 ' w – 59o30 ' n 06o00 ' w – 59o 30 ' n 06o00 ' w – 59o30 ' n 05o00 ' w – 60o00 ' n 05o00 ' w – 6o00 ' n 04o00 ' w


### by way of derogation from paragraph 1 , it shall be permitted to conduct fishing activities using inshore static nets fixed with stakes , scallop dredges , mussel dredges , handlines , mechanised jigging , draft nets and beach seines , pots and creels within the specified areas and time periods , provided that : ### by way of derogation from paragraph 1 , it shall be permitted to conduct fishing activities using inshore static nets fixed with stakes , scallop dredges , mussel dredges , handlines , mechanised jigging , gill and tangle nets , draft nets and beach seines , pots and creels within the specified areas and time periods , provided that :


### no fishing gear other than inshore static nets fixed with stakes , scallop dredges , mussel dredges , handlines , mechanised jigging , draft nets and beach seines , pots and creels are carried on board or deployed ; and ### no fishing gear other than inshore static nets fixed with stakes , scallop dredges , mussel dredges , handlines , mechanised jigging , gill and tangle nets , draft nets and beach seines , pots and creels are carried on board or deployed ; and


### no fish other than mackerel , pollack , saithe and salmon , or shellfish other than molluscs and crustaceans are retained on board , landed or brought ashore . ### no fish other than mackerel , pollack , saithe , haddock , lesser spotted dogfish and salmon , or shellfish other than molluscs and crustaceans are retained on board , landed or brought ashore .


### no more than 10 % of the retained catch by weight is comprised of any mixture of cod , haddock and / or whiting ; ### no more than 3 % of the retained catch by weight is comprised of any mixture of cod and / or whiting ;


### no more than 30 % of the retained catch by weight is comprised of any mixture of cod , haddock and / or whiting ; ### no more than 3 % of the retained catch by weight is comprised of mixture of cod and / or whiting ;


### in particular , fighting climate change is recognised as one of the great challenges which the union faces and the area where urgent international action is necessary . in accordance with the intent stated in the commission communication “a budget for europe 2020” of increasing the climate related proportion of the union budget to at least 20% , this regulation should contribute to that goal . ### in particular , fighting climate change is recognised as one of the great challenges which the union faces and the area where urgent international action is necessary . in accordance with the intent stated in the commission communication “a budget for europe 2020” of increasing the climate - related proportion of the union budget to at least 20% , this regulation should contribute to that goal . it should also help to integrate the environment and climate imperative into the rules governing the organisation of international trade .


### as referred to in article 13 , paragraph 2 of the “erasmus for all” regulation , in order to promote the international dimension of higher education , an indicative amount of eur 1 812 100 000 from the different external instruments , will be allocated to actions of learning mobility to or from non eu countries and to cooperation and policy dialogue with authorities / institutions / organisations from these countries . the provisions of the “erasmus for all” regulation will apply to the use of those funds . ### as referred to in article 13 , paragraph 2 , of the “erasmus for all” regulation , in order to promote the international dimension of higher education , an indicative amount of eur 1 812 100 000 from the different external instruments , will be allocated to actions of learning mobility to or from non - eu countries and to cooperation and policy dialogue with local , regional , and national authorities / institutions / organisations from these countries . the provisions of the “erasmus for all” regulation will apply to the use of those funds .


### the promotion of policy and sectoral dialogues involving union and non - union political , economic , regulatory , environmental , social , research and cultural actors and non - governmental organisations ; ### the promotion of policy and sectoral dialogues involving union and non - union political , economic , regulatory , environmental , social , research and cultural actors and non - governmental organisations and regional and local authorities and associations thereof ;


### the promotion of initiatives and actions of union or mutual interest in areas such as climate change , environmental matters including biodiversity , resource efficiency , raw materials , energy , transport , science , research and innovation , employment and social policy , sustainable development , including promotion of decent work , and corporate social responsibility , south - south trade and cooperation , education , culture , tourism , information and communication technologies , health , justice , customs , taxation , financial , statistics and any other matter pertaining to the union’s specific interests or of mutual interest between the union and third countries ; ### the promotion of initiatives and actions of union or mutual interest in areas such as climate change , environmental matters including biodiversity , resource efficiency , raw materials , energy , transport , science , research and innovation , consolidation of regional and local authorities and civil society , employment and social policy , sustainable development , including promotion of decent work , and corporate social responsibility , north - south and south - south trade and cooperation , education , vocational training , culture , tourism , local development , information and communication technologies , health , justice , customs , taxation , financial , statistics and any other matter pertaining to the union’s specific interests or of mutual interest between the union and third countries ;


### eudamed’s electronic systems regarding devices on the market , the relevant economic operators and certificates should enable the public to be adequately informed about devices on the union market . the electronic system on clinical performance studies should serve as tool for the cooperation between member states and for enabling sponsors to submit , on a voluntary basis , a single application for several member states and , in this case , to report serious adverse events . the electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities . the electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities . ### eudamed’s electronic systems regarding devices on the market , the relevant economic operators and certificates should enable the public to be adequately informed about devices on the union market . the electronic system on clinical performance studies should serve as tool for the cooperation between member states and for enabling sponsors to submit , on a voluntary basis , a single application for several member states and , in this case , to report serious adverse events . the electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities . the electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities . a regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public


### healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats . the national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents . ### healthcare professionals and patients should be empowered to report suspected serious incidents at national level , using harmonised formats , and guaranteeing anonymity , where appropriate . the national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents .


### – diagnosis , prevention , monitoring , treatment or alleviation of disease , ### – diagnosis , prevention , monitoring , prediction , prognosis , treatment or alleviation of disease ,


### for devices for self - testing or near - patient - testing , the information supplied in accordance with section 17 of annex i shall be provided in the language of the member state where the device reaches its intended user . ### for devices for self - testing or near - patient - testing , the information supplied in accordance with section 17 of annex i shall be easily understandable and provided in the language of the member state where the device reaches its intended user .


### manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately take the necessary corrective action to bring that product into conformity , withdraw it or recall it , as appropriate . they shall inform the distributors and , where applicable , the authorised representative accordingly . ### manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately take the necessary corrective action to bring that product into conformity , withdraw it or recall it , as appropriate . they shall inform the responsible national competent authority , the distributors and , where applicable , the authorised representative accordingly .


### to operate its system for the assignment of udis for the period to be determined in the designation which shall at least be three years after its designation ; ### to operate its system for the assignment of udis for the period to be determined in the designation which shall at least be five years after its designation ;


### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body . ### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be made publicly available and written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body .


### where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in annex vi , or that it is failing to fulfil its obligations , the authority shall suspend , restrict , or fully or partially withdraw the notification , depending on the seriousness of the failure to meet those requirements or fulfil those obligations . a suspension shall not exceed a period of one year , renewable once for the same period . where the notified body has ceased its activity , the national authority responsible for notified bodies shall withdraw the notification . ### where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in annex vi , or that it is failing to fulfil its obligations , the authority shall suspend , restrict , or fully or partially withdraw the notification , depending on the seriousness of the failure to meet those requirements or fulfil those obligations . suspension shall apply until a decision to annul the suspension has been reached by the mdcg , which shall follow an assessment by a joint assessment team designated in accordance with the procedure described in article 30 and . where the notified body has ceased its activity , the national authority responsible for notified bodies shall withdraw the notification .


### where the commission ascertains that a notified body no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including the suspension , restriction or withdrawal of the notification if necessary . ### where the commission , in consultation with the medical devices coordination group , decides that a notified body no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including the suspension , restriction or withdrawal of the notification , if necessary , in line with article 34 .


### the commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in article 39 of regulation [ ref . of future regulation on medical devices ] . ### the commission , in consultation with the medical devices coordination group , shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in article 39 of regulation [ ref . of future regulation on medical devices ] .


### within one year from the end of the clinical performance study , the sponsor shall submit to the member states concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in section 2 . 3 . 3 of part a of annex xii . where , for scientific reasons , it is not possible to submit the clinical performance study report within one year , it shall be submitted as soon as it is available . in this case , the clinical performance study protocol referred to in section 2 . 3 . 2 of part a of annex xii shall specify when the results of the clinical performance study are going to be submitted , together with an explanation . ### within one year from the end of the clinical performance study , the sponsor shall submit to the member states concerned the results of the clinical performance study in form of a clinical performance study report referred to in section 2 . 3 . 3 of part a of annex xii . where , for scientific reasons , it is not possible to submit the clinical performance study report within one year , it shall be submitted as soon as it is available . in this case , the clinical performance study protocol referred to in section 2 . 3 . 2 of part a of annex xii shall specify when the results of the clinical performance study are going to be submitted , together with an explanation .


### a serious adverse event that has a causal relationship with the device for performance evaluation , the comparator or the study procedure or where such causal relationship is reasonably possible ; ### any adverse event that has a causal relationship with the device for performance evaluation , the comparator or the study procedure or where such causal relationship is reasonably possible ;


### any serious incident in respect of devices made available on the union market ; ### any incident in respect of devices made available on the union market ;


### the member states shall lay down the provisions on penalties applicable for infringement of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for shall be effective , proportionate , and dissuasive . the member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the provisions on penalties applicable for infringement of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented and sufficiently dissuasive . the penalties provided for shall be effective , proportionate , and dissuasive . the member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them .


### the clinical evidence report referred to in section 3 of annex xii shall be included and / or fully referenced in the technical documentation . ### the clinical evidence report referred to in section 3 of annex xii shall be included and fully referenced in the technical documentation .


### prudent fiscal policy - making should effectively achieve and maintain the medium - term budgetary objective . adherence to the medium - term objective for budgetary positions should allow member states to have a safety margin with respect to the 3% of gdp reference value for the government deficit , to ensure rapid progress towards sustainability , and at the same time to have room for budgetary manoeuvre , in particular taking into account the needs for public investment . ### prudent fiscal policy - making should effectively achieve and maintain the medium - term budgetary objective . adherence to the medium - term objective for budgetary positions should allow member states to have a safety margin with respect to the reference values of 3% of gdp for the government deficit and 60% of gdp for government debt , to ensure rapid progress towards sustainability , and at the same time to have room for budgetary manoeuvre , in particular taking into account the needs for public investment .


### in the preventive part of the stability and growth pact , the incentive for prudent fiscal policy - making should consist of an obligation to lodge an interest - bearing deposit temporarily imposed on a member state whose currency is the euro that is making insufficient progress with budgetary consolidation . this should be the case when , following an initial warning from the commission , a member state persists in conduct which , while not amounting to a violation of the ban on excessive deficits , is imprudent and potentially detrimental to the smooth functioning of economic and monetary union , and the council therefore issues a recommendation in accordance with article 121 of the treaty . ### in the preventive part of the stability and growth pact , the incentive for prudent fiscal policy - making should consist of an obligation to lodge an interest - bearing deposit temporarily imposed on a member state whose currency is the euro that is making insufficient progress with budgetary consolidation . this should be the case when , following an initial warning from the commission , a member state persists in conduct which , while not amounting to a violation of the ban on excessive deficits or excessive government debt , is imprudent and potentially detrimental to the smooth functioning of economic and monetary union , and the council therefore issues a recommendation in accordance with article 121 of the treaty .


### in the corrective part of the stability and growth pact , sanctions for member states whose currency is the euro should take the form of an obligation to lodge a non - interest - bearing deposit linked to a council decision establishing the existence of an excessive deficit and the obligation to pay a fine in the event of non - compliance with a council recommendation to correct an excessive government deficit . these sanctions should be imposed irrespective of whether or not an interest - bearing deposit has previously been imposed on the member state concerned . ### in the corrective part of the stability and growth pact , sanctions for member states whose currency is the euro should take the form of an obligation to lodge a non - interest - bearing deposit linked to a council decision establishing the existence of an excessive deficit or excessive government debt and the obligation to pay a fine in the event of non - compliance with a council recommendation to correct an excessive government deficit or excessive government debt . these sanctions should be imposed irrespective of whether or not an interest - bearing deposit has previously been imposed on the member state concerned .


### the non - interest - bearing deposit should be released upon correction of the excessive deficit while the interest on such deposits and the fines collected should be distributed among member states whose currency is the euro which do not have an excessive deficit and which are not the subject of an excessive imbalance procedure either . ### the non - interest - bearing deposit should be released upon correction of the excessive deficit or excessive government debt while the interest on such deposits and the fines collected should be allocated to the permanent crisis mechanism . until the establishment of the european monetary fund , those fines shall be credited to the european financial stability facility .


### if the council decides in accordance with article 126 of the treaty that an excessive deficit exists in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 of the treaty that an excessive deficit or excessive government debt exist in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty .


### by way of derogation from article 65 the payer may be obliged to bear the losses relating to any unauthorised payment transactions , up to a maximum of eur 50 , resulting from the use of a lost or stolen payment instrument or from the misappropriation of a payment instrument . ### by way of derogation from article 65 the payer may be obliged to bear the losses relating to any unauthorised payment transactions , up to a maximum of eur 50 or equivalent , resulting from the use of a lost or stolen payment instrument or from the misappropriation of a payment instrument .


### the information referred to in paragraph 2 shall be mentioned in an easily , directly , prominently and permanently accessible way on the website of the payment service provider , where one exists , in the general terms and conditions of the contract between the payment service provider and the payment service user and in invoices and receipts relating to such contracts . it shall specify how further information on the out - of - court redress entity concerned and on the conditions for using it can be accessed . ### the information referred to in paragraph 1 shall be mentioned in a clear , comprehensible and easily accessible way on the trader’s website , where one exists and if applicable in the general terms and conditions of sales or service contracts between the trader and a consumer .


### weather conditions endangering the safe operation of the ship should include , but not be limited to , strong winds , heavy seas , strong currents , difficult ice conditions and extremely high or low water levels . ### weather conditions and natural disasters endangering the safe operation of the ship should include , but not be limited to , strong winds , heavy seas , strong currents , difficult ice conditions , extremely high or low water levels , hurricanes and tornados , fires , floods and earthquakes .


### extraordinary circumstances should include , but not be limited to , terrorist attacks , labour conflicts , landing any sick , injured or dead person , search and rescue operations at sea or on inland waterways , measures necessary to protect the environment , decisions taken by traffic management bodies or port authorities , or decisions by the competent authorities with regard to public order and safety as well as to cover urgent transport needs . ### extraordinary circumstances should include , but not be limited to , terrorist attacks , wars and military or civil armed conflicts , uprisings , military or illegal confiscations , labour conflicts , landing any sick , injured or dead person , search and rescue operations at sea or on inland waterways , measures necessary to protect the environment , decisions taken by traffic management bodies or port authorities , or decisions by the competent authorities with regard to public order and safety as well as to cover urgent transport needs .


### on passenger services where the port of embarkation is situated outside the territory of a member state and the port of disembarkation is situated in the territory of a member state , provided that the service is operated by a union carrier ; ### on passenger services where the port of embarkation is situated outside the territory of a member state and the port of disembarkation is situated in the territory of a member state , provided that the service is operated by a union carrier as defined by article 3 ;


### carriers , travel agents and tour operators shall not refuse to accept a reservation , to issue or otherwise provide a ticket or to embark persons on the grounds of disability or of reduced mobility . ### carriers , travel agents and tour operators shall not refuse to accept a reservation , to issue or provide a ticket or to embark or disembark persons on the grounds of disability or of reduced mobility .


### reservations and tickets shall be offered to disabled persons and persons with reduced mobility at no additional cost . ### reservations and tickets shall be offered to disabled persons and persons with reduced mobility at no additional cost under the same conditions that apply to all other passengers .


### notwithstanding article 7 , carriers , travel agents and tour operators may refuse to accept a reservation from , to issue or otherwise provide a ticket to or to embark a person , on the grounds of disability or of reduced mobility : ### notwithstanding article 7 , carriers , travel agents and tour operators may refuse to accept a reservation from , to issue or provide a ticket to or to embark a person , on the grounds of disability or of reduced mobility :