### it is created using electronic signature creation data that the signatory can , with high level of confidence , use under his sole control ; and ### it is created using an electronic signature creation device that the signatory can use under his sole control ; and


### 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 with respect to and in full compliance with union legislation on accessibility of public sector bodies websites , persons with disabilities should be able to use trust services and electronic identification services and end user products used in the provision of those services on equal bases with other consumers .


### the commission may , by means of implementing acts , establish reference numbers of standards for qualified certificates for website authentication . compliance with the requirements laid down in annex iv shall be presumed where a qualified certificate for website authentication 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 qualified certificates for website authentication . the commission shall ensure , that stakeholder input is duly considered , preferably in form of an impact assessment , when defining standards to be used for the purpose of this regulation . compliance with the requirements laid down in annex iv shall be presumed where a qualified certificate for website authentication 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 .


### mutual recognition and acceptance ### mutual recognition


### ' electronic identification ' means the process of using person identification data in electronic form unambiguously representing a natural or legal person ; ### ' electronic identification ' means the process of using identification data in electronic form unambiguously representing a natural or legal person ;


### when a transaction requires a qualified electronic seal from a legal person , a qualified electronic signature from the authorised representative of the legal person should be equally acceptable . ### when national or union law requires a qualified electronic seal from a legal person , a qualified electronic signature from the authorised representative of the legal person should be equally acceptable .


### trust services providers from third countries ### qualified trust services providers from third countries


### this regulation lays down rules for electronic identification and electronic trust services for electronic transactions with a view to ensuring the proper functioning of the internal market . ### this regulation lays down rules for electronic identification and electronic trust services for electronic transactions with the aim to develop the digital single market by guaranteeing a high degree of security , and strengthening confidence and trust in cross - border electronic transactions of the digital environment .


### the commission may , by means of implementing acts , establish reference numbers of standards for processes for sending and receiving data . compliance with the requirements laid down in paragraph 1 shall be presumed where the process for sending and receiving data 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 processes for sending and receiving data . the commission shall ensure , that stakeholder input is duly considered , preferably in form of an impact assessment , when defining standards to be used for the purpose of this regulation . compliance with the requirements laid down in paragraph 1 shall be presumed where the process for sending and receiving data 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 .


### member states and / or other entities in charge of the implementation of projects of common interest or contributing to their implementation shall take the necessary legal , administrative , technical and financial measures in compliance with the corresponding specifications of this regulation . ### member states and / or other entities , including regional and local authorities , in charge of the implementation of projects of common interest or contributing to their implementation shall take the necessary legal , administrative , technical and financial measures in compliance with the corresponding specifications of this regulation .


### draft by the court of justice ### once the number of judges of the general court has been increased , the question of their appointment will naturally arise . regarding the system for appointing judges , member states should agree on rules offering every guarantee as regards the independence and impartiality and the competence and suitability of the persons appointed , as well as making for equality and balance in terms of their home member states .


### draft by the court of justice 7 . in article 48 , the figure ‘ 27’ shall be replaced by the figure ‘ 39’ . ### article 48 shall be replaced by the following : ' the general court shall consist of 39 judges . when , every three years , the judges are partially replaced , 20 and 19 judges shall be replaced alternately . '


### draft by the court of justice in order to enable the specialised courts to continue to function satisfactorily in the absence of a judge who , while not suffering from disablement deemed to be total , is prevented from participating in judicial business for an extended period of time , provision should be made for the possibility of attaching temporary judges to those courts . ### in order to enable the specialised courts to continue to function satisfactorily in the absence of a judge who , while not suffering from disablement deemed to be total , is prevented from participating in judicial business for an extended period of time , provision should be made for the possibility of attaching temporary judges to those courts . the appointment of temporary judges should offer every guarantee as regards the independence and impartiality and the competence and suitability of the persons appointed , as well as making for equality and balance in terms of their home member states .


### in cases where the determination of a fishing mortality rate that restores and maintains stocks above levels capable of producing maximum sustainable yield is not possible , multiannual plans shall provide for precautionary measures ensuring a comparable degree of conservation of the relevant stocks . ### in cases where the determination of a fishing mortality rate that restores and maintains stocks to levels capable of producing maximum sustainable yield is not possible , multiannual plans shall provide for precautionary measures ensuring a comparable degree of conservation of the relevant stocks .


### the common fisheries policy shall apply the precautionary approach to fisheries management , and shall aim to ensure , by 2015 , that exploitation of living marine biological resources restores and maintains populations of harvested species above levels capable of producing the maximum sustainable yield . ### the common fisheries policy shall apply the precautionary approach to fisheries management , and shall aim to maintain or restore populations of harvested species to levels capable of producing the maximum sustainable yield by 2020 .


### by border – warzsawa – poznań – frankfurt / oder – berlin – hannover – osnabrück – enschede – utrecht – amsterdam / rotterdam – felixstowe – birmingham / manchester – liverpool ### by border – warzsawa – poznań – frankfurt / oder – berlin – hannover – osnabrück – hengelo / twente – enschede – utrecht – amsterdam / rotterdam – felixstowe – birmingham / manchester – liverpool rail : upgrading of several sections


### removing bottlenecks and bridging missing links , to be measured by the number of new and improved cross - border connections and removed bottlenecks on transport routes which have benefited from cef ; ### removing bottlenecks and bridging missing links , particularly in order to cover mountainous and island regions and regions with low population density , to be measured by the number of new and improved cross - border connections and removed bottlenecks on transport routes which have benefited from the cef ;


### inland transport connections to ports and airports , development of multi - modal platforms and of ports ; ### inland transport connections to ports and airports , development of multi - modal platforms and of ports in all regions of the eu ;


### applicable rules for the transport sector under this regulation shall apply to these specific calls . when implementing these calls , greatest possible priority shall be given to projects respecting the national allocations under the cohesion fund . ### applicable rules for the transport sector under this regulation shall apply to these specific calls . until 31 december 2016 , the selection of projects eligible for financing shall respect the national allocations under the cohesion fund . as of 1 january 2017 , resources transferred to the connecting europe facility which have not been committed to a transport infrastructure project , shall be made available to all member states eligible to the cohesion fund to finance transport infrastructure projects according to this regulation .


### vat shall not be an eligible cost . ### non - refundable vat shall be an eligible cost .


### by border – warzsawa – poznań – frankfurt / oder – berlin – hannover – osnabrück – enschede – utrecht – amsterdam / rotterdam – felixstowe – birmingham / manchester – liverpool ### by border – warzsawa – poznań – frankfurt / oder – berlin – hannover – west - german canals , mittellandkanal – osnabrück – enschede – utrecht – amsterdam / rotterdam – felixstowe – birmingham / manchester – liverpool pre - identified sections : west - german canals , mittellandkanal , hannover – magdeburg - berlin mode : iww description / dates : upgrading incl . links to the other modes


### transport : eur 31 694 000 000 , out of which eur 10 000 000 000 shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; ### transport : eur 31 694 000 000 , of which eur 10 000 000 000 should be earmarked to finance transport projects on the transport core network in the member states eligible for the cohesion fund ;


### in accordance with this directive , member states shall : ### the minimum requirements of this directive shall be no impediment to member states retaining or introducing provisions on the protection of personal data that ensure a higher level of protection .


### 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 . ### the carrying out of processing by a processor must be governed by a legal act or a written agreement stipulating that the processor shall act only on instructions from the controller .


### protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data ; and ### protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of their personal data and privacy ; and


### 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 must choose a processor providing sufficient guarantees to implement the technical and organisational measures set out in article 27 ; that the processing will also meet the requirements of the provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject ; and that the data subject will follow the instructions of the controller .


### member states shall provide that each supervisory authority exercises , on the territory of its own member state , the powers conferred on it in accordance with this directive . ### member states shall provide that each supervisory authority exercises , on the territory of its own member state , a least the powers conferred on it in accordance with this directive .


### member states shall ensure that records are kept of at least the following processing operations : collection , alteration , consultation , disclosure , combination or erasure . the records of consultation and disclosure shall show in particular the purpose , date and time of such operations and as far as possible the identification of the person who consulted or disclosed personal data . ### member states shall ensure that records are kept of at least the following processing operations : collection , alteration , consultation , disclosure , combination or erasure . the records of consultation and disclosure shall show in particular the purpose , date and time of such operations and the identification of the person who consulted or disclosed personal data , and the identity of the recipient of such data .


### ensuring a consistent and high level of protection of the personal data of individuals and facilitating the exchange of personal data between competent authorities of members states is crucial in order to ensure effective judicial co - operation in criminal matters and police cooperation . to that aim , the level of protection of the rights and freedoms of individuals with regard to the processing of personal data by competent authorities for the purposes of prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties must be equivalent in all member states . effective protection of personal data throughout the union requires strengthening the rights of data subjects and the obligations of those who process personal data , but also equivalent powers for monitoring and ensuring compliance with the rules for the protection of personal data in the member states . ### ensuring a consistent and high level of protection of the personal data of individuals and facilitating the exchange of personal data between competent authorities of members states is crucial in order to ensure effective judicial co - operation in criminal matters and police cooperation . to that aim , minimum standards must be ensured in all member states with regard to any processing of personal data by competent authorities for the purposes of prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties .


### the commission may adopt , where necessary , implementing acts for specifying the requirements laid down in paragraphs 1 and 2 to various situations , notably encryption standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 57 . ### the member states may adopt , where necessary , provisions for specifying the requirements laid down in paragraphs 1 and 2 to various situations , notably encryption standards .


### 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 . ### measures which produce an adverse legal effect for the data subject or significantly affects him and which is based solely on automated processing of data intended to evaluate certain personal aspects relating to the data subject shall be permitted only if authorised by a law which also lays down measures to safeguard the data subject ' s legitimate interests .


### the controller shall carry out the erasure without delay . ### member states shall lay down whether the data subject may assert this right directly against the controller or through the intermediary of the competent national supervisory authority . 2a . if the data subject asserts their rights against the controller and the latter refuses the rectification or completion , the controller must inform the data subject in writing on the refusal of rectification , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy .


### member states shall prohibit the processing of personal data revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , of genetic data or of data concerning health or sex life . 2 . paragraph 1 shall not apply where : the processing is authorised by a law providing appropriate safeguards ; the processing is necessary to protect the vital interests of the data subject or of another person ; the processing relates to data which are manifestly made public by the data subject . ### the processing of personal data revealing racial or ethnic origin , political opinions , religious or philosophical beliefs or trade - union membership and of data concerning health or sex life shall be permitted only if the processing is absolutely necessary and authorised by a law providing appropriate safeguards ; or


### this directive lays down the rules relating to the protection of individuals with regard to the processing of personal data by competent authorities for the purposes of the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties . ### this directive lays down the rules relating to the protection of individuals with regard to the processing of personal data by competent authorities for the purposes of risk prevention , the investigation , detection or prosecution of criminal offences and the execution of criminal penalties .


### member states should ensure that a transfer to a third country only takes place if it is necessary for the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , and the controller in the third country or international organisation is an authority competent within the meaning of this directive . a transfer may take place in cases where the commission has decided that the third country or international organisation in question ensures an adequate level or protection , or when appropriate safeguards have been adduced . ### member states should ensure that a transfer to a third country only takes place if it is necessary for the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , and the controller in the third country or international organisation is an authority competent within the meaning of this directive .


### member states shall provide that any information and any communication relating to the processing of personal data are to be provided by the controller to the data subject in an intelligible form , using clear and plain language . ### member states shall provide that any information and any communication relating to the processing of personal data are to be provided by the controller to the data subject in as intelligible a form as possible , using clear and plain language .


### the transfer is necessary for the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties ; ### the transfer is necessary for the prevention of risk , the investigation , detection or prosecution of criminal offences or the execution of criminal penalties ; and


### the processing relates to data which are manifestly made public by the data subject . ### the processing relates to data which are manifestly made public by the data subject , provided that they are relevant and strictly necessary for the purpose pursued .


### member states shall ensure that , as far as possible , the different categories of personal data undergoing processing are distinguished in accordance with their degree of accuracy and reliability . ### the competent authorities shall ensure that , as far as possible , personal data are factually accurate , complete and , if necessary , up to date .


### member states shall provide that each controller and processor maintains documentation of all processing systems and procedures under their responsibility . ### all competent authorities shall maintain detailed documentation of all processing systems and procedures under their responsibility . 1a . transmissions of personal data are to be logged or documented for the purposes of verification of the lawfulness of the data processing , self - monitoring and ensuring proper data integrity and security . 1b . the logs and documents so produced must be made available to the supervisory authority upon request . the supervisory authority shall use this information only for the purpose of checking the lawfulness of the data processing and ensuring proper data integrity and security .


### in accordance with this directive , member states shall : ### the minimum requirements of this directive shall be no impediment to member states retaining or introducing provisions on the protection of personal data that ensure a higher level of protection .


### monitors and ensures the application of the provisions adopted pursuant to this directive and its implementing measures ; ### monitors and ensures the application of , at least , the provisions adopted pursuant to this directive and its implementing measures ;


### the records shall be used solely for the purposes of verification of the lawfulness of the data processing , self - monitoring and for ensuring data integrity and data security . ### the records shall be used solely for the purposes of verification of the lawfulness of the data processing , self - monitoring and for ensuring data integrity and data security , or for purposes of auditing , either by the data protection officer or by the data protection authority .


### member states shall provide that the controller informs the data subject in writing on any refusal of rectification , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy . ### member states shall lay down whether the data subject may assert these rights directly against the controller or through the intermediary of the competent national supervisory authority . 2a . if the data subject asserts their rights against the controller and the latter refuses the rectification or completion , the controller must inform the data subject in writing on the refusal of rectification , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy


### where no decision adopted in accordance with article 41 of regulation … . / 2012 exists , the commission shall assess the adequacy of the level of protection , giving consideration to the following elements : ### where no decision adopted in accordance with article 41 of regulation … . / 2012 exists , the commission shall assess the adequacy of the level of protection , giving consideration to all the circumstances generally surrounding data transfers or categories of data transfer which can be assessed without reference to specific transfer operations . the assessment shall give particular consideration to the following elements :


### member states shall provide for the right of the data subject to request , in particular in cases referred to in article 13 , that the supervisory authority checks the lawfulness of the processing . ### member states shall provide for the right of the data subject to request , within the bounds of what is set out in articles 12 and 13 , that the supervisory authority checks the lawfulness of the processing .


### member states shall prohibit the processing of personal data revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , of genetic data or of data concerning health or sex life . ### member states shall prohibit the processing of personal data revealing private life , race or ethnic origin , political opinions , religion or beliefs , trade - union membership , of genetic data or of data concerning health or sex life .


### the processing is authorised by a law providing appropriate safeguards ; ### the processing is absolutely necessary and authorised by a law providing appropriate safeguards ; or


### to avoid prejudicing the prevention , detection , investigation and prosecution of criminal offences or the execution of criminal penalties ; ### to avoid prejudicing the prevention of risks , the detection , investigation and prosecution of criminal offences or the execution of criminal penalties ;


### if a processor processes personal data other than as instructed by the controller , the processor shall be considered to be a controller in respect of that processing and shall be subject to the rules on joint controllers laid down in article 20 . ### if a processor processes personal data without or in contravention of an instruction from the controller and in the absence of an appropriate legal obligation , the processor shall be liable for the processing as if he or she were a controller .


### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the rights and guarantees of the person concerned :


### 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 . ### the carrying out of processing by a processor must be governed by a legal act or a written agreement stipulating that the processor shall act only on instructions from the controller .


### in respect of automated data processing , each member state shall provide that the controller or processor , following an evaluation of the risks , implements measures designed to : ### in respect of automated data processing , each member state shall take suitable measures to :


### member states shall provide that each supervisory authority draws up an annual report on its activities . the report shall be made available to the commission and the european data protection board . ### member states shall provide that each supervisory authority draws up an annual report on its activities at regular intervals of not more than three years .


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


### member states shall provide that the controller and the processor implements appropriate technical and organisational measures to ensure a level of security appropriate to the risks represented by the processing and the nature of the data to be protected , having regard to the state of the art and the cost of their implementation . ### member states shall provide that the controller implements technical and organisational measures to prevent : the unintentional or unlawful destruction , accidental loss , unauthorised alteration , unauthorised disclosure or access , in particular where the processing involves transmission over a network or making available by granting direct automated access , and all other unlawful forms of processing personal data . having regard to the state of the art and the cost of their implementation , these measures must ensure a level of security appropriate to the risks represented by the processing and the nature of the data to be protected .


### member state shall provide that the controller informs the data subject of the right to request the intervention of the supervisory authority pursuant to paragraph 1 . ### member state shall provide that the controller informs the data subject , at the request of the latter , of the right to request the intervention of the supervisory authority pursuant to paragraph 1 .


### the principles of protection should apply to any information concerning an identified or identifiable natural person . to determine whether a natural person is identifiable , account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify the individual . the principles of data protection should not apply to data rendered anonymous in such a way that the data subject is no longer identifiable . ### the principles of protection should apply to any information concerning an identified or identifiable natural person . to determine whether a natural person is identifiable , account should be taken of all the means likely reasonably to be used either by the controller or by any other person working together with the controller to identify the individual . the principles of data protection should not apply to data rendered anonymous in such a way that the data subject is no longer identifiable .


### kept in a form which permits identification of data subjects for no longer than it is necessary for the purposes for which the personal data are processed ; ### kept in a form which permits identification of data subjects but for no longer than is necessary for the purposes for which the personal data are processed ;


### the controller shall carry out the erasure without delay . ### member states shall lay down whether the data subject may assert this right directly against the controller or through the intermediary of the competent national supervisory authority . 2a . if the data subject asserts their rights against the controller and the latter refuses the rectification or completion , the controller must inform the data subject in writing on the refusal of rectification , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy .


### ensuring a consistent and high level of protection of the personal data of individuals and facilitating the exchange of personal data between competent authorities of members states is crucial in order to ensure effective judicial co - operation in criminal matters and police cooperation . to that aim , the level of protection of the rights and freedoms of individuals with regard to the processing of personal data by competent authorities for the purposes of prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties must be equivalent in all member states . effective protection of personal data throughout the union requires strengthening the rights of data subjects and the obligations of those who process personal data , but also equivalent powers for monitoring and ensuring compliance with the rules for the protection of personal data in the member states . ### ensuring a consistent and high level of protection of the personal data of individuals and facilitating the exchange of personal data between competent authorities of members states is crucial in order to ensure effective judicial co - operation in criminal matters and police cooperation . to that aim , minimum standards must be ensured in all member states with regard to any processing of personal data by competent authorities for the purposes of prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties .


### the protection of individuals should be technological neutral and not depend on the techniques used ; otherwise this would create a serious risk of circumvention . the protection of individuals should apply to processing of personal data by automated means , as well as to manual processing if the data are contained or are intended to be contained in a filing system . files or sets of files as well as their cover pages , which are not structured according to specific criteria , should not fall within the scope of this directive . this directive should not apply to the processing of personal data in the course of an activity which falls outside the scope of union law , in particular concerning national security , or to data processed by the union institutions , bodies , offices and agencies , such as europol or eurojust . ### the protection of individuals should be technological neutral and not depend on the techniques used ; otherwise this would create a serious risk of circumvention . the protection of individuals should apply to processing of personal data by automated means , as well as to manual processing if the data are contained or are intended to be contained in a filing system . files or sets of files as well as their cover pages , which are not structured according to specific criteria , should not fall within the scope of this directive . this directive should not apply to the processing of personal data in the course of an activity which falls outside the scope of union law , in particular concerning national security .


### adequate , relevant , and not excessive in relation to the purposes for which they are processed ; ### adequate , relevant , and limited to the minimum necessary in relation to the purposes for which they are processed ; they shall only be processed if , and as long as , the purposes could not be fulfilled by processing information that does not involve personal data ;


### member states shall provide that any information and any communication relating to the processing of personal data are to be provided by the controller to the data subject in an intelligible form , using clear and plain language . ### member states shall provide that any information and any communication relating to the processing of personal data are to be provided by the controller to the data subject in an intelligible form , using clear and plain language . if the data subject is a child that information should be provided in a child - friendly way .


### the transfer is necessary for the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties ; ### the transfer is necessary for the prevention of risk , the investigation , detection or prosecution of criminal offences or the execution of criminal penalties ; and


### the delegation of power referred to in article 28 may be revoked at any time by the european parliament or by the council . a decision of revocation 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 . ### the delegation of power referred to in article 34 may be revoked at any time by the european parliament or by the council . a decision of revocation 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 .


### member states shall ensure that , as far as possible , personal data based on facts are distinguished from personal data based on personal assessments . ### the competent authorities shall ensure that personal data which are inaccurate , incomplete or no longer up to date are not transmitted or made available . to that end , the competent authorities shall , as far as practicable , verify the quality of personal data before they are transmitted or made available . as far as possible , in all transmissions of data , available information shall be added which enables the receiving member state to assess the degree of accuracy , completeness , up - to - dateness and reliability . if personal data were transmitted without request the receiving authority shall verify without delay whether these data are necessary for the purpose for which they were transmitted . 2a . if it emerges that incorrect data have been transmitted or data have been unlawfully transmitted , the recipient must be notified without delay . the recipient shall be obliged to rectify the data without delay in accordance with paragraph 1 and article 15 or to erase them in accordance with article 16 .


### member states shall ensure that , as far as possible , personal data based on facts are distinguished from personal data based on personal assessments . ### the competent authorities shall ensure that personal data which are inaccurate , incomplete , or no longer up to date are not transmitted or made available . to that end , the competent authorities shall , as far as practicable , verify the quality of personal data before they are transmitted or made available . as far as possible , in all transmissions of data , available information shall be added which enables the receiving member state to assess the degree of accuracy , completeness , up - to - dateness , and reliability . if personal data were transmitted without request the receiving authority shall verify without delay whether those data are necessary for the purpose for which they were transmitted . if it emerges that incorrect data have been transmitted or data have been transmitted unlawfully , the recipient must be notified without delay . the recipient shall be obliged to rectify the data without delay in accordance with paragraph 1 and article 15 or to erase them in accordance with article 16 .


### 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 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 prohibit the processing of personal data revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , of genetic data or of data concerning health or sex life . ### the processing of personal data revealing racial or ethnic origin , political opinions , religious or philosophical beliefs or trade - union membership or of data concerning health or sex life shall be permitted only if


### to protect the rights and freedoms of others . ### to protect the data subject or the rights and freedoms of others .


### member states shall prohibit the processing of personal data revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , of genetic data or of data concerning health or sex life . 2 . paragraph 1 shall not apply where : the processing is authorised by a law providing appropriate safeguards ; the processing is necessary to protect the vital interests of the data subject or of another person ; the processing relates to data which are manifestly made public by the data subject . ### the processing of personal data revealing racial or ethnic origin , political opinions , religious or philosophical beliefs or trade - union membership and of data concerning health or sex life shall be permitted only if the processing is absolutely necessary and authorised by a law providing appropriate safeguards ; or


### member states shall provide that the controller and the processor implements appropriate technical and organisational measures to ensure a level of security appropriate to the risks represented by the processing and the nature of the data to be protected , having regard to the state of the art and the cost of their implementation . ### member states shall provide that the controller implements technical and organisational measures to prevent : the unintentional or unlawful destruction , accidental loss , unauthorised alteration , unauthorised disclosure or access , in particular where the processing involves transmission over a network or making available by granting direct automated access , and all other unlawful forms of processing personal data . having regard to the state of the art and the cost of their implementation , these measures must ensure a level of security appropriate to the risks represented by the processing and the nature of the data to be protected .


### member states shall ensure that the controller documents the grounds for omitting the communication of the factual or legal reasons on which the decision is based . ### member states shall ensure that the controller documents the assessment referred to in paragraph 2 as well as the grounds for restricting the communication of the factual or legal reasons on which the decision is based .


### the data subject opposes their erasure and requests the restriction of their use instead . ### erasure would affect the data subject’s legitimate interests or the data subject opposes their erasure and requests the restriction of their use instead .


### 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 must choose a processor providing sufficient guarantees to implement the technical and organisational measures set out in article 27 ; that the processing will also meet the requirements of the provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject ; and that the data subject will follow the instructions of the controller .


### 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 . ### measures which produce an adverse legal effect for the data subject or significantly affects him and which is based solely on automated processing of data intended to evaluate certain personal aspects relating to the data subject shall be permitted only if authorised by a law which also lays down measures to safeguard the data subject ' s legitimate interests .


### member states shall provide that the controller informs the data subject in writing on any refusal of rectification , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy . ### member states shall lay down whether the data subject may assert this right directly against the controller or through the intermediary of the competent national supervisory authority . 3 . if the data subject asserts their rights directly against the controller and the latter refuses the rectification or completion , the controller must inform the data subject in writing on the refusal of rectification , on the reasons for the refusal and on the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy .


### different degrees of accuracy and reliability of personal data ### factual accuracy


### 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 where the processing does not comply with the provisions adopted pursuant to articles 4 , 6 , 7 and 8 of this directive .


### member state shall provide that the controller informs the data subject of the right to request the intervention of the supervisory authority pursuant to paragraph 1 . ### member states shall provide that the controller informs the data subject of the right to request the intervention of the supervisory authority pursuant to paragraph 1 .


### this directive lays down the rules relating to the protection of individuals with regard to the processing of personal data by competent authorities for the purposes of the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties . ### this directive lays down the rules relating to the protection of individuals with regard to the processing of personal data by competent authorities for the purposes of protection against and prevention of risks to public security , preparedness for subsequent prosecution , the prevention , investigation , detection or prosecution of criminal offences and the execution of criminal penalties .


### member states shall provide that the controller informs the recipient of the personal data of any processing restrictions and takes all reasonable steps to ensure that these restrictions are met . ### member states shall provide that the controller informs the recipient of the personal data of any processing restrictions and takes all reasonable steps to ensure that these restrictions are met . the controller shall also notify the recipient of the personal data of any update , rectification or erasure of data , and the recipient shall in turn make the corresponding notification in the event that the data has subsequently been transferred .


### conducts investigations either on its own initiative or on the basis of a complaint , or on request of another supervisory authority , and informs the data subject concerned , if the data subject has addressed a complaint , of the outcome of the investigations within a reasonable period ; ### conducts investigations on the basis of a complaint , or on request of another supervisory authority , and informs the data subject concerned , if the data subject has addressed a complaint , of the outcome of the investigations within a reasonable period ; the supervisory authority may also conduct such investigations on its own initiative , within the limits of national legislation ;


### protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data ; and ### protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of their personal data and privacy ; and


### ' data subject ' means an identified natural person or a natural person who can be identified , directly or indirectly , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to an identification number , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural or social identity of that person ; ### ' data subject ' means an identified natural person or a natural person who can be identified , directly or indirectly , by means reasonably likely to be used by the controller or by any other natural or legal person working together with the controller , in particular by reference to an identification number , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural or social identity of that person ;


### member states may adopt legislative measures delaying , restricting or omitting the provision of the information to the data subject to the extent that , and as long as , such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures delaying or restricting the provision of the information to the data subject to the extent that , and as long as , such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the fundamental rights and the legitimate interests of the person concerned :


### an authorised csd may only have a participation in a legal person whose activities are limited to the provision of services set out in sections a and b of the annex . ### an authorised csd may have a participation in any legal person irrespective of the industry . such participation shall be subject to approval by the competent authority .


### any question with respect to proprietary aspects in relation to financial instruments held by a csd shall be governed by the law of the country where the account is maintained . ### any question with respect to proprietary aspects in relation to financial instruments held by a csd shall be governed by the law of the country where the account is maintained , except if the financial instrument is issued in another country , in which case the applicable law is the law of that country .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec , and regulation no 41 / 2009 as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods covered under article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### 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 , food for special medical purposes , and food for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec , commission regulation no 41 / 2009 . 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 , and food for people intolerant to gluten 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 . ### 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 , milk based drinks intended for young children 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 , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , milk based drinks intended for young children , 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 and the process for placing on the market of food resulting from scientific and technological innovations 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 .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ' gluten - free ' and ' very low gluten ' and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . in addition , the statement ' gluten - free ' may be used for foodstuffs for normal consumption and other food for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten , which do not allow the use of the statement ' very low gluten ' for these foods . such food for specialised nutrition intended for people intolerant to gluten shall be maintained in this regulation , as providing such safe food intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for food for special dietary use for persons intolerant to gluten . also the conditions of use of the claim ‘ gluten - free’ for food for normal consumption should be maintained in regulation no 41 / 2009 .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ' gluten - free ' and ' very low gluten ' and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . the recently adopted regulation no 1169 / 2011 on the provision of food information to consumers provides for the adoption by the commission of implementing acts regulating voluntary information on the possible and unintentional presence in food of a substance causing allergies or intolerances . for reasons of coherence and simplification of the legal framework , the commission should be granted a mandate under regulation no 1169 / 2011 to also adopt implementing acts regulating voluntary information on the absence or reduced presence in food of substances causing intolerances , such as gluten and lactose , and to withdraw commission regulation no 41 / 2009 . it is necessary that the fic regulation is amended to that effect and that the required implementing provisions be adopted by the commission prior to the entry into application of this regulation . the implementing act concerned should maintain on the foods in question the statements ' gluten - free ' and ' very low gluten ' and their associated conditions of use , as well as an indication of the persons for whom the foods are intended , as currently regulated under regulation no 41 / 2009 , and hence provide for the same level of consumer protection .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , milk based drinks intended for young children , food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec commission regulation no 41 / 2009 , as well as commission directive 96 / 8 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , milk based drinks intended for young children , food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 . in addition , the concept of ‘ specialised nutrition’ should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market using current union acts .


### 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 , milk - based drinks for young children 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 , milk - based drinks for young children 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 and the procedure for placing on the market foodstuffs resulting from scientific and technological innovations 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 .


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . in addition , the statement ‘ gluten - free’ may be used for foodstuffs for normal consumption and other food for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten which do not allow the use of the statement ‘ very low gluten’ for these foods . such food for specialized nutrition intended for people intolerant to gluten shall be maintained in this regulation , as providing such safe food intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for food for special dietary use for persons intolerant to gluten . also the conditions of use of the claim ‘ gluten - free’ for food for normal consumption should be maintained in regulation no 41 / 2009 .


### criteria should be laid down to determine the procedure to be used for the adoption of implementing acts . in order to achieve greater consistency and in order to ensure that procedural requirements are proportionate to the nature of the implementing acts to be adopted , those criteria should be binding . ### criteria should be laid down to determine the procedure to be used for the adoption of implementing acts , in order to achieve greater consistency and predictability as to the nature of the implementing acts to be adopted . however , those criteria should be of a non - binding nature and the procedure to be used should be determined in each basic act .


### criteria should be laid down to determine the procedure to be used for the adoption of implementing acts . in order to achieve greater consistency and in order to ensure that procedural requirements are proportionate to the nature of the implementing acts to be adopted , those criteria should be binding . ### criteria should be laid down to determine the procedure to be used for the adoption of implementing acts . in order to achieve greater consistency , the procedural requirements should be proportionate to the nature and impact of the implementing acts to be adopted .


### a basic act may provide for the application of the examination procedure or the advisory procedure , according to the type of implementing measures concerned . 2 . the examination procedure may only apply for the adoption of : implementing measures of general scope ; other implementing measures relating to : common agricultural and common fisheries policies ; ii ) environment , security and safety or protection of the health or safety of humans , animals or plants ; iii ) common commercial policy . 3 . for all other implementing measures , and for implementing measures referred to in paragraph 2 where it is considered to be appropriate , the advisory procedure shall apply . ### a basic act may provide for the application of the advisory procedure or the examination procedure taking into account the nature or the impact of the implementing acts required . 2 . the examination procedure applies , in particular , for the adoption of : implementing acts of general scope ; other implementing acts relating to : common agricultural and common fisheries policies ; ii ) environment , security and safety or protection of the health or safety of humans , animals or plants ; iii ) common commercial policy ; iiia ) taxation ; iiib ) programmes with substantial budgetary implications . 3 . the advisory procedure applies , as a general rule , for the adoption of implementing acts not falling within the ambit of paragraph 2 , but it may also apply , in duly justified cases , for the adoption of the implementing acts referred to in that paragraph .


### the examination procedure may only apply for the adoption of : implementing measures of general scope ; other implementing measures relating to : common agricultural and common fisheries policies ; ii ) environment , security and safety or protection of the health or safety of humans , animals or plants ; iii ) common commercial policy . ### without prejudice to paragraph 1 , the examination procedure shall , where appropriate , apply for the adoption of implementing measures of general scope and specific measures with substantial implications , including of a budgetary nature .


### the commission shall keep a register of committee proceedings which shall contain : the agendas of committee meetings , the summary records , together with the lists of the authorities and organisations to which the persons designated by the member states to represent them belong , the draft measures on which the committees are asked to deliver an opinion , the results of voting , the final draft measures following the opinion of the committees , the information concerning the final adoption of the measures by the commission , and statistical data on the working of the committees . 2 . the european parliament and the council shall have access to the information referred to in paragraph 1 . 3 . the references of all documents referred to in points to of paragraph 1 as well as the information referred to in point of paragraph 1 shall be made public in the register . ### the commission shall keep a register of committee proceedings which shall contain : a list of committees , the agendas of committee meetings , the summary records , together with the lists of the authorities and organisations to which the persons designated by the member states to represent them belong , the draft acts on which the committees are asked to deliver an opinion , the voting results , the final draft acts following the opinion of the committees , information concerning the final adoption of the acts by the commission , and statistical data on the work of the committees . 1a . the commission shall also publish an annual report on the work of the committees . 2 . the european parliament and the council shall have access to the information referred to in paragraph 1 in accordance with the applicable rules . 2a . at the same time as they are sent to the committee members , the commission shall make available to the european parliament and the council the documents referred to in points , and of paragraph 1 whilst also informing them of the availability of such documents . 3 . the references of all documents referred to in points to of paragraph 1 as well as the information referred to in point of paragraph 1 shall be made public in the register .


### the examination procedure should only apply for the adoption of measures of general scope designed to implement basic acts and specific measures with a potentially important impact . that procedure should provide for the control of the member states in such a way that measures cannot be adopted if they are not in conformity with the opinion of the committee , except in very exceptional circumstances , where the commission should be able , in spite of a negative opinion , to adopt and apply measures for a limited period of time . the commission should be able to review the draft measures in the event that no opinion is delivered by the committee , taking into account the views expressed within the committee . ### the examination procedure should in particular apply for the adoption of measures of general scope designed to implement basic acts and specific measures with a potentially important impact . that procedure should provide for the control of the member states in such a way that acts cannot be adopted if they are not in conformity with the opinion of the committee , except in very exceptional circumstances , where the commission should be able , in spite of a negative opinion , to adopt and apply acts for a limited period of time . the commission should be able to review the draft acts in the event that no opinion is delivered by the committee , taking into account the views expressed within the committee .


### the examination procedure should only apply for the adoption of measures of general scope designed to implement basic acts and specific measures with a potentially important impact . that procedure should provide for the control of the member states in such a way that measures cannot be adopted if they are not in conformity with the opinion of the committee , except in very exceptional circumstances , where the commission should be able , in spite of a negative opinion , to adopt and apply measures for a limited period of time . the commission should be able to review the draft measures in the event that no opinion is delivered by the committee , taking into account the views expressed within the committee . ### the examination procedure should provide for the control in such a way that measures cannot be adopted if they are not in conformity with the opinion of the committee , except in very exceptional circumstances , where the commission should be able , in spite of a negative opinion , to adopt and apply measures for a limited period of time . the commission should be able to review the draft measures in the event that no opinion is delivered by the committee , taking into account the views expressed within the committee .


### the advisory procedure should apply in all other cases and where it is considered to be most appropriate . ### the advisory procedure should as a general rule apply in all other cases and where it is considered to be most appropriate .


### decision 1999 / 468 / ec should be repealed . in order to ensure the transition between the regime provided for in decision 1999 / 468 / ec and this regulation , any reference in existing legislation to the procedures provided for in that decision should , with the exception of the regulatory procedure with scrutiny provided for in article 5a thereof , be understood as a reference to the corresponding procedures provided for in this regulation . the effects of article 5a of decision 1999 / 468 / ec should be maintained for the purposes of existing basic acts which refer to that article . ### decision 1999 / 468 / ec should be repealed and references to procedures provided for in that decision contained in existing basic acts should be adapted in the shortest possible time , and in any event not later than 31 december 2012 , to the new rules on delegated and implementing powers set out in articles 290 and 291 of the treaty on the functioning of the european union . pending that adaptation , in order to ensure the transition between the regime provided for in decision 1999 / 468 / ec and this regulation , the procedures provided for in this regulation should provisionally apply where existing legislation makes reference to the procedures provided for in that decision , with the exception of the regulatory procedure with scrutiny provided for in article 5a thereof which should continue to apply provisionally .


### this regulation lays down the rules and general principles governing the mechanisms which shall apply in cases where a legally binding union act requires that the adoption of binding implementing acts by the commission be subject to the control of member states . ### this regulation lays down the rules and general principles governing the procedures and the mechanisms of control which shall apply in cases where a legally binding union act confers implementing powers on the commission where uniform conditions for implementing that act are needed .


### this regulation lays down the rules and general principles governing the mechanisms which shall apply in cases where a legally binding union act requires that the adoption of binding implementing acts by the commission be subject to the control of member states . ### this regulation lays down the rules and general principles governing the mechanisms which shall apply in cases where a legally binding union act identifies the need for uniform conditions of implementation and requires that the adoption of implementing acts by the commission be subject to the control of member states .


### this regulation lays down the rules and general principles governing the mechanisms which shall apply in cases where a legally binding union act requires that the adoption of binding implementing acts by the commission be subject to the control of member states . ### this regulation lays down the rules and general principles governing the mechanisms which apply in cases where a legally binding union act identifies the need for uniform conditions of implementation and consequently requires that the adoption of implementing acts by the commission be subject to the control of member states .


### the committee shall deliver its opinion by a qualified majority as provided for in article 16 and of the treaty on european union . 2 . if the draft measures are in accordance with the opinion of the committee , the commission shall adopt these measures , unless exceptional circumstances or new elements have arisen which would justify the measures not being adopted . in such cases , the chairperson may submit to the committee a new draft of the measures to be taken . 3 . if the draft measures are not in accordance with the opinion of the committee , the commission shall not adopt those measures . the chairperson may submit to the committee the draft measures for further deliberation or submit an amended version of the draft measures . 4 . if no opinion is delivered , the commission may adopt the draft measures . where the commission does not adopt the draft measures , the chairperson may submit to the committee an amended version of the draft measures . 5 . by derogation from paragraph 3 , the commission may adopt draft measures which are not in accordance with the opinion of the committee where their non adoption within an imperative deadline would create a significant disruption of the markets or a risk for the security or safety of humans or for the financial interests of the union . in such a case the commission shall immediately inform the committee of its reasons for adopting the measures and may submit them to a second deliberation of the committee . if the measures adopted are not in accordance with the second opinion of the committee , or if the measures have not been submitted to a second deliberation within a month after their adoption , the commission shall repeal the measures forthwith . if the measures are in accordance with the second opinion of the committee , or if no opinion is delivered , those measures shall remain in force . ### where the examination procedure applies , the committee shall deliver its opinion by the majority laid down in article 16 and of the treaty on european union and , where applicable , 238 of the treaty on the functioning of the european union , for acts to be adopted on a proposal from the commission . the votes of the representatives of the member states within the committee shall be weighted in the manner set out in those articles . 2 . if the committee delivers a positive opinion , the commission shall adopt the draft acts . 3 . without prejudice to article 5b , if the committee delivers a negative opinion , the commission shall not adopt those acts . where implementing acts are deemed to be necessary , the chair may either submit the draft acts within one month to the appeal committee for further deliberation or submit to the committee within two months an amended version of the draft acts . 4 . if no opinion is delivered , the commission may adopt the draft acts , except in the case provided for in the next subparagraph . where the commission does not adopt the draft acts , the chair may submit to the committee an amended version of the draft acts . without prejudice to article 5b , the commission shall not adopt the draft acts where : – the measures concern taxation , financial services , the protection of the health or safety of humans , animals or plants , or definitive multilateral safeguard measures , or – the basic act so provides , or – a simple majority of the component members of the committee opposes them . in any of the cases referred to in the second subparagraph , where implementing acts are deemed to be necessary , the chair may either submit the draft acts within one month to the appeal committee for further deliberation or submit to the committee within two months an amended version of the draft acts . 5 . by way of derogation from paragraph 4 , the following procedure shall apply for the adoption of definitive antidumping or countervailing measures , in cases where no opinion is delivered within the examination committee and a simple majority of its component members opposes the draft act . the commission shall conduct consultations with the member states . fourteen days at the earliest and one month at the latest after the meeting of the committee , the commission shall inform the committee members of the results of those consultations and submit a draft act to the appeal committee . by way of derogation from article 3 , the appeal committee shall meet 14 days at the earliest and one month at the latest after the submission of the draft act . the appeal committee shall deliver its opinion in accordance with article 5a . the time - limits laid down in this paragraph are without prejudice to the need to ensure that the deadlines laid down in the relevant basic acts are respected .


### this regulation shall enter into force on 1 october 2010 . article 10 of this regulation shall apply from 1 december 2010 . this regulation is binding in its entirety and directly applicable in all member states . ### this regulation shall enter into force on 1 march 2011 . this regulation is binding in its entirety and directly applicable in all member states .


### the european parliament and the council should be kept informed of committee proceedings on a regular basis . ### the european parliament and the council should be promptly informed of committee proceedings on a regular basis .


### where a basic act provides for the application of the procedures referred to in articles 4 , 5 and 6 , the provisions set out in paragraphs 2 to 6 of this article shall apply . 2 . the commission shall be assisted by a committee composed of the representatives of the member states and chaired by a representative of the commission . 3 . the chairperson shall submit to the committee a draft of the measures to be taken . 4 . the committee shall examine the draft measures . until an opinion has been delivered , the chairperson may present amended versions of the draft measures in order to take into account the discussions within the committee . for that purpose , the chairperson may convene several meetings of the committee . the committee shall deliver its opinion on the draft within a time - limit which the chairperson may lay down according to the urgency of the matter . 5 . the chairperson may obtain the committee’s opinion by written procedure . he or she shall send the committee members the draft measures on which their opinion is sought and shall lay down a time - limit according to the urgency of the matter . any committee member who does not explicitly oppose or abstain before the time - limit laid down expires is considered to have given their tacit agreement to the draft measures . within the time - limit laid down in accordance with the previous subparagraph , any committee member may ask for the written procedure to be terminated and for the draft measures to be examined at a committee meeting . the chairperson may decide to maintain the written procedure or to terminate the written procedure without result , in which case a committee meeting shall be convened as soon as possible . 6 . the committee’s opinion shall be recorded in the minutes . each member state may ask to have its position recorded in the minutes . ### where a basic act provides for the application of the procedures referred to in articles 4 to 6 , paragraphs 2 to 7 of this article shall apply . 2 . the commission shall be assisted by a committee composed of representatives of member states . the committee shall be chaired by a representative of the commission . the chair shall not take part in the committee vote . 3 . the chair shall submit to the committee a draft of the acts to be adopted by the commission . except in duly justified cases , he or she shall convene a meeting not less than 14 days from the submission to the committee of the draft of the acts to be adopted and of the draft agenda . the committee shall deliver its opinion on the draft within a time - limit which the chair may lay down according to the urgency of the matter . time - limits shall be proportionate and shall offer representatives of the member states early and effective opportunities to examine the draft acts and express their views . 4 . until the committee delivers an opinion , any committee member may suggest amendments and the chair may present amended versions of the draft acts . the chair shall endeavour to find solutions which command the widest possible support within the committee . he or she shall inform the committee of the manner in which the discussions and suggestions for amendments have been taken into account , in particular as regards those suggestions which are largely supported within the committee . 5 . in duly justified cases , the chair may obtain the committee’s opinion by written procedure . he or she shall send the committee members the draft acts and shall lay down a time - limit according to the urgency of the matter . any committee member who does not explicitly oppose or abstain before the expiry of that time - limit shall be considered to have given his or her tacit agreement to the draft acts . unless otherwise provided in the basic act , the written procedure shall be terminated without result where , within the time - limit referred to in the first subparagraph , the chair so decides or a committee member so requests . in such a case , the chair shall convene a committee meeting within a reasonable time . 6 . the committee’s opinion shall be recorded in the minutes . each member of the committee shall have the right to ask to have his or her position recorded in the minutes . the commission shall send the minutes to the committee members without delay . 6a . where applicable , the control mechanism includes referral to an appeal committee . the appeal committee shall adopt its own rules of procedure by simple majority , on a proposal from the commission . where the appeal committee is seised , it shall meet at the earliest 14 days , except in duly justified cases , and at the latest six weeks , after the date of referral . without prejudice to paragraph 3 , the appeal committee shall deliver its opinion within two months from the date of referral . a representative of the commission shall chair the meetings of the appeal committee . the chair shall set the date of the appeal committee meeting in close cooperation with the members of the committee , in order to enable member states and the commission to ensure an appropriate level of representation . the commission shall convene the first meeting of the appeal committee within one month after the entry into force of this regulation in order to adopt its rules of procedure .


### the european parliament and the council shall have access to the information referred to in paragraph 1 . ### the european parliament , the council and the member states shall have equal access to the information referred to in paragraph 1 . to that end , the european parliament and the council shall be sent , at the same time as the members of the committees and on the same terms , all the information referred to in paragraph 1 .


### the european parliament and the council shall have access to the information referred to in paragraph 1 . ### the european parliament , the council and the member states shall have equal access to the information referred to in paragraph 1 . to that end , the european parliament and the council shall be sent , at the same time as the members of the committees and on the same terms , all information referred to in paragraph 1 .


### by way of derogation from articles 4 and 5 , a basic act may provide that , on imperative grounds of urgency , the provisions set out in paragraphs 2 to 5 of this article shall apply . 2 . the commission shall adopt measures which shall apply immediately . 3 . the chairperson shall without delay submit the measures referred to in paragraph 2 to the relevant committee in order to obtain its opinion in accordance with the procedure provided for in the basic act . 4 . in the case of the examination procedure , where the measures are not in accordance with the opinion of the committee pursuant to article 5 , the commission shall repeal the measures adopted in accordance with paragraph 2 . 5 . by way of derogation from paragraph 4 , the commission may maintain the measures in force on grounds related to the protection of the environment or of the health or safety of humans , animals or plants , the conservation of marine resources , for security and safety reasons , or to avoid disruption or threat of disruption of the markets . in those cases , the chairperson shall without delay either resubmit to the committee the same measures for a second deliberation or submit an amended version of the measures . the measures referred to in paragraph 2 shall remain in force until they are repealed or replaced by another implementing act . ### by way of derogation from articles 4 and 5 , a basic act may provide that , on duly justified imperative grounds of urgency , the provisions set out in paragraphs 2 to 5 of this article shall apply . 2 . the commission shall adopt acts which shall apply immediately and shall remain in force for a period not exceeding six months unless the basic act provides otherwise . 3 . at the latest 14 days after their adoption , the chair shall submit the acts referred to in paragraph 2 to the relevant committee in order to obtain its opinion . 4 . in the case of the examination procedure , where the committee delivers a negative opinion , the commission shall immediately repeal the acts adopted in accordance with paragraph 2 . 5 . where the commission adopts provisional anti - dumping or countervailing measures , the procedure provided for in this article shall apply . the commission shall take provisional action after consulting or , in cases of extreme urgency , after informing the member states . in this case , consultations shall take place ten days , at the latest , after notification to the member states of the action taken by the commission .


### decision 1999 / 468 / ec should be repealed . in order to ensure the transition between the regime provided for in decision 1999 / 468 / ec and this regulation , any reference in existing legislation to the procedures provided for in that decision should , with the exception of the regulatory procedure with scrutiny provided for in article 5a thereof , be understood as a reference to the corresponding procedures provided for in this regulation . the effects of article 5a of decision 1999 / 468 / ec should be maintained for the purposes of existing basic acts which refer to that article . ### decision 1999 / 468 / ec should be repealed . in order to ensure the transition between the regime provided for in decision 1999 / 468 / ec and this regulation , a transitional scheme should apply whereby any reference in existing legislation to the procedures provided for in that decision should , with the exception of the regulatory procedure with scrutiny provided for in article 5a thereof , be understood as a reference to the corresponding procedure provided for in this regulation . the effects of article 5a of decision 1999 / 468 / ec should be maintained for the purposes of existing basic acts which refer to that article . that transitional scheme should be without prejudice to the legislator ' s discretion as to the procedure to be chosen for any future legislative acts .