### the relevant provisions of this regulation with regard to procedures and the conduct of investigations , excluding those relating to time - limits , shall apply to any review carried out pursuant to paragraphs 2 , 3 and 4 . reviews carried out pursuant to paragraphs 2 and 3 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review . in any event , reviews pursuant to paragraphs 2 and 3 shall be concluded within 15 months of initiation . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 9 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . reviews pursuant to paragraph 4 shall in all cases be concluded within nine months of the date of initiation . if a review carried out pursuant to paragraph 2 is initiated while a review under paragraph 3 in ongoing in the same proceeding , the review pursuant to paragraph 3 shall be concluded at the same time as the review pursuant to paragraph 2 . ### the relevant provisions of this regulation with regard to procedures and the conduct of investigations , excluding those relating to time - limits , shall apply to any review carried out pursuant to paragraphs 2 , 3 and 4 . reviews carried out pursuant to paragraphs 2 and 3 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review . in any event , reviews pursuant to paragraphs 2 and 3 shall be concluded within 14 months of initiation . no later than seven and a half months after the initiation of the investigation pursuant to article 6 the commission shall consult the member states on the basis of the findings of the investigation . the member states shall in this consultation indicate to the commission whether they expect an intense controversy in the decision making process pursuant to article 9 for definitive action which would be likely to trigger the appeal procedure referred to in article 6 of regulation no 182 / 2011 . if so the commission may decide , no later than 8 months after the initiation of the investigation , to extend the time limit for a period up to , but in no case longer than , 15 months . the commission shall make this decision public . reviews pursuant to paragraph 4 shall in all cases be concluded within nine months of the date of initiation . if a review carried out pursuant to paragraph 2 is initiated while a review under paragraph 3 in ongoing in the same proceeding , the review pursuant to paragraph 3 shall be concluded at the same time as the review pursuant to paragraph 2 .


### the relevant provisions of this regulation with regard to procedures and the conduct of investigations , excluding those relating to time - limits , shall apply to any review carried out pursuant to paragraphs 2 , 3 and 4 . reviews carried out pursuant to paragraphs 2 and 3 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review . in any event , reviews pursuant to paragraphs 2 and 3 shall be concluded within 15 months of initiation . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 9 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . reviews pursuant to paragraph 4 shall in all cases be concluded within nine months of the date of initiation . if a review carried out pursuant to paragraph 2 is initiated while a review under paragraph 3 in ongoing in the same proceeding , the review pursuant to paragraph 3 shall be concluded at the same time as the review pursuant to paragraph 2 ' ### the relevant provisions of this regulation with regard to procedures and the conduct of investigations , excluding those relating to time - limits , shall apply to any review carried out pursuant to paragraphs 2 , 3 and 4 . reviews carried out pursuant to paragraphs 2 and 3 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review . in any event , reviews pursuant to paragraphs 2 and 3 shall be concluded within 14 months of initiation . no later than seven and a half months after the initiation of the investigation pursuant to article 6 the commission shall consult the member states on the bases of the findings of the investigation . the member states shall in this consultation indicate to the commission whether they expect an intense controversy in the decision making process pursuant to article 9 for definitive action with the need to submit the draft implementing act after the delivery of a negative opinion within the examination procedure pursuant to article 5 of the regulation no 182 / 2011 to the appeal body pursuant to article 6 of the same regulation . if so the commission may decide , no later than eight months after the initiation of the investigation , to extend the time limit for a period up to , but in no case longer than , 15 months . the commission shall make this decision public . reviews pursuant to paragraph 4 shall in all cases be concluded within nine months of the date of initiation . if a review carried out pursuant to paragraph 2 is initiated while a review under paragraph 3 in ongoing in the same proceeding , the review pursuant to paragraph 3 shall be concluded at the same time as the review pursuant to paragraph 2 .


### reviews carried out pursuant to articles 18 and 19 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review . in any event , reviews pursuant to articles 18 and 19 shall be concluded within 15 months of initiation . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 9 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . ### reviews carried out pursuant to articles 18 and 19 shall be carried out expeditiously and shall normally be concluded within 11 months of the date of initiation of the review . in any event , reviews pursuant to articles 18 and 19 shall be concluded within 14 months of initiation . no later than seven and a half month after the initiation of the investigation pursuant to article 11 the commission shall consult the member states on the bases of the findings of the investigation . the member states shall in this consultation indicate to the commission whether they expect an intense controversy in the decision making process pursuant to articles 14 and 15 for definitive action with the need to submit the draft implementing act after the delivery of a negative opinion within the examination procedure pursuant to article 5 of the regulation no 182 / 2011 to the appeal body pursuant to article 6 of the same regulation . if so the commission may decide , no later than 8 months after the initiation of the investigation , to extend the time limit for a period up to , but in no case longer than , 15 months . the commission shall make this decision public .


### reviews carried out pursuant to articles 18 and 19 shall be carried out expeditiously and shall normally be concluded within 12 months of the date of initiation of the review . in any event , reviews pursuant to articles 18 and 19 shall be concluded within 15 months of initiation . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 9 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . ### reviews carried out pursuant to articles 18 and 19 shall be carried out expeditiously and shall normally be concluded within 11 months of the date of initiation of the review . in any event , reviews pursuant to articles 18 and 19 shall be concluded within 14 months of initiation . no later than seven and a half month after the initiation of the investigation pursuant to article 11 the commission shall consult the member states on the basis of the findings of the investigation . the member states shall in this consultation indicate to the commission whether they expect an intense controversy in the decision making process pursuant to articles 14 and 15 for definitive action which would be likely to trigger the appeal procedure referred to in article 6 of regulation no 182 / 2011 if so the commission may decide , no later than 8 months after the initiation of the investigation , to extend the time limit for a period up to , but in no case longer than , 15 months . the commission shall make this decision public .


### the provisional duties shall be imposed no earlier than 60 days , and no later than 9 months , from the initiation of the proceedings . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , to a period up to , but in no case longer than , 12 months . ### the provisional duties shall be imposed no earlier than 60 days , and no later than 8 months , from the initiation of the proceedings . in case the member states indicate to the commission pursuant to article 11 that they expect an intense controversy in the decision making process pursuant to articles 14 and 15 for definitive action with the need to submit the draft implementing act after the delivery of a negative opinion within the examination procedure pursuant to article 5 of the regulation no 182 / 2011 to the appeal body pursuant to article 6 of the same regulation , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , to a period up to , but in no case longer than , 9 months .


### provisional duties may be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given an adequate opportunity to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the union industry , and if the union interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days and no later than 9 months from the initiation of the proceedings . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , to a period up to , but in no case longer than , 12 months . ### provisional duties may be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given an adequate opportunity to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the union industry , and if the union interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days and no later than 8 months from the initiation of the proceedings . in case the member states indicate to the commission pursuant to article 6 that they expect an intense controversy in the decision making process pursuant to article 9 for definitive action with the need to submit the draft implementing act after the delivery of a negative opinion within the examination procedure pursuant to article 5 of the regulation no 182 / 2011 to the appeal body pursuant to article 6 of the same regulation , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , to a period up to , but in no case longer than , 9 months .


### provisional duties may be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given an adequate opportunity to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the union industry , and if the union interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days and no later than 9 months from the initiation of the proceedings . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , to a period up to , but in no case longer than , 12 months . ### provisional duties may be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given an adequate opportunity to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the union industry , and if the union interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days and no later than 8 months from the initiation of the proceedings . in the event that the member states indicate to the commission pursuant to article 6 that they expect an intense controversy in the decision making process pursuant to article 9 for definitive action which would be likely to trigger the appeal procedure referred to in article 6 of regulation no 182 / 2011 , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , to a period up to , but in no case longer than , 9 months .


### draft by the court of justice ### the basic principle should be that the general court should comprise at least one judge and at most two judges having the nationality of each member state .


### draft by the court of justice consequently , the necessary measures should be taken to address this situation , and the possibility , provided for by the treaties , of increasing the number of judges of the general court is such as to enable both the volume of pending cases and the excessive duration of proceedings before the general court to be reduced within a short time . ### consequently , the necessary measures should be taken to address this situation , and the possibility , provided for by the treaties , of increasing the number of judges of the general court from 27 to 39 is such as to enable both the volume of pending cases and the excessive duration of proceedings before the general court to be reduced within a short time .


### draft by the court of justice the parliament and the council , acting in accordance with article 257 tfeu , may attach temporary judges to the specialised courts in order to cover the absence of judges who , while not suffering from disablement deemed to be total , are prevented from participating in judicial business for an extended period of time . in that event , the parliament and the council shall lay down the conditions under which the temporary judges shall be appointed , their rights and duties , the detailed rules governing the performance of their duties and the circumstances in which they shall cease to perform those duties . ### the parliament and the council , acting in accordance with article 257 tfeu , may attach temporary judges to the specialised courts in order to cover the absence of judges who , while not suffering from disablement deemed to be total , are prevented from participating in judicial business for an extended period of time . in that event , the parliament and the council shall lay down the conditions under which the temporary judges shall be appointed , their rights and duties , the detailed rules governing the performance of their duties and the circumstances in which they shall cease to perform those duties . those provisions shall ensure , moreover , that the temporary judges enjoy the same rights and are entitled to assume the same functions as permanent judges , in order to guarantee the uncompromised authority of the court ' s judgments .


### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , the controller or the processor acting on the controller ' s behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data . ### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , the controller shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data .


### the controller or the processor may be exempted from this liability , in whole or in part , if the controller or the processor proves that they are not responsible for the event giving rise to the damage . ### the controller may be exempted from this liability , in whole or in part , if the controller proves that it is not responsible for the event giving rise to the damage .


### within the limits of this regulation , personal data may be processed for historical , statistical or scientific research purposes only if : ### within the limits of this regulation , personal data may be processed for historical , statistical or scientific purposes under paragraph 2 of article 6 and point of article 9 only if :


### in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission for : specifying standard forms in relation to the processing of personal data of a child ; standard procedures and forms for exercising the rights of data subjects ; standard forms for the information to the data subject ; standard forms and procedures in relation to the right of access ; the right to data portability ; standard forms in relation to the responsibility of the controller to data protection by design and by default and to the documentation ; specific requirements for the security of processing ; the standard format and the procedures for the notification of a personal data breach to the supervisory authority and the communication of a personal data breach to the data subject ; standards and procedures for a data protection impact assessment ; forms and procedures for prior authorisation and prior consultation ; technical standards and mechanisms for certification ; the adequate level of protection afforded by a third country or a territory or a processing sector within that third country or an international organisation ; disclosures not authorized by union law ; mutual assistance ; joint operations ; decisions under the consistency mechanism . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers46 . in this context , the commission should consider specific measures for micro , small and medium - sized enterprises . ### in implementing the provisions of this regulation , it shall be ensured that no mandatory requirements for specific technical features are imposed on products and services , including terminal or other electronic communications equipment , which could impede the placing of equipment on the market and the free circulation of such equipment in and between member states .


### in order to demonstrate compliance with this regulation , the controller or processor should document each processing operation . each controller and processor should be obliged to co - operate with the supervisory authority and make this documentation , on request , available to it , so that it might serve for monitoring those processing operations . ### in order to demonstrate compliance with this regulation , the controller should document each processing operation under its responsibility . each controller should be obliged to co - operate with the supervisory authority and make this documentation , on request , available to it , so that it might serve for monitoring those processing operations .


### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , the controller or the processor acting on the controller ' s behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data . ### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , the controller shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data . a single assessment shall be sufficient to address a set of processing operations that present similar risks .


### a transfer based on standard data protection clauses or binding corporate rules as referred to in points , or of paragraph 2 shall not require any further authorisation . ### a transfer based on points , , or of paragraph 2 shall not require any further authorisation .


### the principles of protection should apply to any information concerning an identified or identifiable person . to determine whether a 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 only to specific information concerning an identified or identifiable person . to determine whether a person is identifiable , account should be taken : only of those means likely reasonably to be used by the controller or by any other natural or legal person to identify the individual , and of the reasonable likeliness of a person being identified . the principles of data protection should not apply to data rendered anonymous in such a way that the data subject is no longer identifiable from the data .


### the controller shall carry out the erasure without delay , except to the extent that the retention of the personal data is necessary : ### the controller shall carry out the erasure without undue delay , except to the extent that the retention and dissemination of the personal data is necessary :


### ‘ controller’ means the natural or legal person , public authority , agency or any other body which alone or jointly with others determines the purposes , conditions and means of the processing of personal data ; where the purposes , conditions and means of processing are determined by union law or member state law , the controller or the specific criteria for his nomination may be designated by union law or by member state law ; ### ' controller ' means the natural or legal person , public authority , agency or any other body which alone or jointly with others determines the purposes of the processing of personal data ; where the purposes of processing are determined by union law or member state law , the controller or the specific criteria for his nomination may be designated by union law or by member state law ;


### the controller shall implement mechanisms for ensuring that , by default , only those personal data are processed which are necessary for each specific purpose of the processing and are especially not collected or retained beyond the minimum necessary for those purposes , both in terms of the amount of the data and the time of their storage . in particular , those mechanisms shall ensure that by default personal data are not made accessible to an indefinite number of individuals . ### such measures and procedures shall : take due account of existing technical standards and regulations in the area of public safety and security follow the principle of technology , service and business model neutrality be based on global industry - led efforts and standards take due account of international developments


### before a supervisory authority adopts a measure referred to in paragraph 2 , this supervisory authority shall communicate the draft measure to the european data protection board and the commission . ### before the competent supervisory authority adopts a measure referred to in paragraph 2 , this competent supervisory authority shall communicate the draft measure to the european data protection board and the commission .


### the controller or processor shall ensure that the data protection officer performs the duties and tasks independently and does not receive any instructions as regards the exercise of the function . the data protection officer shall directly report to the management of the controller or the processor . ### the data protection organisation or data protection officer shall perform his or her duties and tasks independently .


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


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


### in order to demonstrate compliance with this regulation , the controller or processor should document each processing operation . each controller and processor should be obliged to co - operate with the supervisory authority and make this documentation , on request , available to it , so that it might serve for monitoring those processing operations . ### in order to demonstrate compliance with this regulation , the controller should document each processing operation . each controller should be obliged to cooperate with the supervisory authority and make this documentation , on request , available to it , so that it might serve for monitoring those processing operations .


### ‘ representative’ means any natural or legal person established in the union who , explicitly designated by the controller , acts and may be addressed by any supervisory authority and other bodies in the union instead of the controller , with regard to the obligations of the controller under this regulation ; ### ‘ representative’ means any natural or legal person established in the union who , explicitly designated by the controller , acts and shall be addressed by the competent supervisory authority , with regard to the obligations of the controller under this regulation ;


### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects , in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages or for other reasons , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the european data protection board and to the commission . ### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects within their territory , when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages , by clear breach or unjustified inaction of the competent supervisory authority , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the competent supervisory authority , the european data protection board , the commission and the controller or processor .


### where a controller determines the purposes , conditions and means of the processing of personal data jointly with others , the joint controllers shall determine their respective responsibilities for compliance with the obligations under this regulation , in particular as regards the procedures and mechanisms for exercising the rights of the data subject , by means of an arrangement between them . ### where a controller determines the purposes of the processing of personal data jointly with others , the joint controllers shall determine their respective responsibilities for compliance with the obligations under this regulation , in particular as regards the procedures and mechanisms for exercising the rights of the data subject , by means of an arrangement between them .


### having regard to the state of the art and the cost of implementation , the controller shall , both at the time of the determination of the means for processing and at the time of the processing itself , implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject . ### having regard to the state of the art and the cost of implementation , the controller shall , at the time of the determination of the means for processing at the time of the processing itself , and when significant changes are made to the processing environment , implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject .


### in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission for : specifying standard forms in relation to the processing of personal data of a child ; standard procedures and forms for exercising the rights of data subjects ; standard forms for the information to the data subject ; standard forms and procedures in relation to the right of access ; the right to data portability ; standard forms in relation to the responsibility of the controller to data protection by design and by default and to the documentation ; specific requirements for the security of processing ; the standard format and the procedures for the notification of a personal data breach to the supervisory authority and the communication of a personal data breach to the data subject ; standards and procedures for a data protection impact assessment ; forms and procedures for prior authorisation and prior consultation ; technical standards and mechanisms for certification ; the adequate level of protection afforded by a third country or a territory or a processing sector within that third country or an international organisation ; disclosures not authorized by union law ; mutual assistance ; joint operations ; decisions under the consistency mechanism . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers46 . in this context , the commission should consider specific measures for micro , small and medium - sized enterprises . ### in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission . in implementing the provisions of this regulation , it shall be ensured that no mandatory requirements for specific technical features are imposed on products and services , including terminal or other electronic communications equipment , which could impede the placing of equipment on the market and the free circulation of such equipment in and between member states .


### the controller or processor acting on the controller ' s behalf shall consult the supervisory authority prior to the processing of personal data in order to ensure the compliance of the intended processing with this regulation and in particular to mitigate the risks involved for the data subjects where : ### the controller or processor acting on the controller ' s behalf may consult the supervisory authority prior to the processing of personal data in order to ensure the compliance of the intended processing with this regulation and in particular to mitigate the risks involved for the data subjects where :


### complying with the requirements for prior authorisation or prior consultation of the supervisory authority pursuant to article 34 and ; ### existence of appropriate documentation of data processing to enable compliance with the obligations arising from the regulation ;


### in the case of a personal data breach , the controller shall without undue delay and , where feasible , not later than 24 hours after having become aware of it , notify the personal data breach to the supervisory authority . the notification to the supervisory authority shall be accompanied by a reasoned justification in cases where it is not made within 24 hours . ### in the case of a personal data breach relating to special categories of personal date , personal data which are subject to professional secrecy , personal data relating to criminal offences or to the suspicion of a criminal act or personal data relating to bank or credit card accounts , which seriously threaten the rights or legitimate interests of the data subject , the controller shall without undue delay notify the personal data breach to the supervisory authority .


### in order to demonstrate compliance with this regulation , the controller or processor should document each processing operation . each controller and processor should be obliged to co - operate with the supervisory authority and make this documentation , on request , available to it , so that it might serve for monitoring those processing operations . ### in order to demonstrate compliance with this regulation , the controller should document each processing operation under its responsibility . each controller should be obliged to co - operate with the supervisory authority and make this documentation , on request , available to it , so that it might serve for monitoring those processing operations .


### the controller shall carry out the erasure without delay , except to the extent that the retention of the personal data is necessary : ### the controller shall carry out the erasure without undue delay , except to the extent that the retention and dissemination of the personal data is necessary :


### when using online services , individuals may be associated with online identifiers provided by their devices , applications , tools and protocols , such as internet protocol addresses or cookie identifiers . this may leave traces which , combined with unique identifiers and other information received by the servers , may be used to create profiles of the individuals and identify them . it follows that identification numbers , location data , online identifiers or other specific factors as such need not necessarily be considered as personal data in all circumstances . ### when using online services , individuals may be associated with online identifiers provided by their devices , applications , tools and protocols , such as internet protocol addresses or cookie identifiers . this may leave traces which , combined with unique identifiers and other information received by the servers , may be used to create profiles of the individuals and identify them . it follows that identification numbers , location data , online identifiers or other specific factors need not necessarily be considered as personal data in all circumstances .


### processing of data relating to criminal convictions or related security measures is carried out either under the control of official authority or when the processing is necessary for compliance with a legal or regulatory obligation to which a controller is subject , or for the performance of a task carried out for important public interest reasons , and in so far as authorised by union law or member state law providing for adequate safeguards . a complete register of criminal convictions shall be kept only under the control of official authority . ### processing of data relating to criminal convictions or related security measures is carried out either subject to the conditions and safeguards referred to in article 83a or under the supervision of a supervisory authority or when the processing is necessary for compliance with or to avoid a breach of a legal or regulatory obligation to which a controller is subject , or for the performance of a task carried out for important public interest reasons , and in so far as authorised by union law or member state law providing for adequate safeguards . a complete register of criminal convictions shall be kept only under the control of official authority


### the protection of the rights and freedoms of data subjects as well as the responsibility and liability of controllers and processor , also in relation to the monitoring by and measures of supervisory authorities , requires a clear attribution of the responsibilities under this regulation , including where a controller determines the purposes , conditions and means of the processing jointly with other controllers or where a processing operation is carried out on behalf of a controller . ### the protection of the rights and freedoms of data subjects as well as the responsibility and liability of controllers and processor , also in relation to the monitoring by and measures of supervisory authorities , requires a clear attribution of the responsibilities under this regulation , including where a controller determines the purposes of the processing jointly with other controllers or where a processing operation is carried out on behalf of a controller .


### prior authorisation and prior consultation ### prior consultation


### if the data processed by a controller do not permit the controller to identify a natural person , the controller shall not be obliged to acquire additional information in order to identify the data subject for the sole purpose of complying with any provision of this regulation . ### if the data processed by a controller do not permit the controller , through means used by the controller , to identify a natural person , the controller shall not be obliged to acquire additional information in order to identify the data subject for the sole purpose of complying with any provision of this regulation .


### where a processing operation is to be carried out on behalf of a controller , the controller shall choose a processor providing sufficient guarantees to implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject , in particular in respect of the technical security measures and organizational measures governing the processing to be carried out and shall ensure compliance with those measures . ### where a processing operation is to be carried out on behalf of a controller and which involves the processing of data that would permit the processor to reasonably identify the data subject , the controller shall choose a processor providing sufficient guarantees to implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject , in particular in respect of the technical security measures and organizational measures governing the processing to be carried out and shall ensure compliance with those measures . the controller remains solely responsible for ensuring compliance with the requirements of this regulation .


### the controller or the processor may be exempted from this liability , in whole or in part , if the controller or the processor proves that they are not responsible for the event giving rise to the damage . ### the controller may be exempted from this liability , in whole or in part , if the controller proves that it is not responsible for the event giving rise to the damage .


### processing of data relating to criminal convictions or related security measures is carried out either under the control of official authority or when the processing is necessary for compliance with a legal or regulatory obligation to which a controller is subject , or for the performance of a task carried out for important public interest reasons , and in so far as authorised by union law or member state law providing for adequate safeguards . a complete register of criminal convictions shall be kept only under the control of official authority . ### processing of data relating to criminal convictions or related security measures is carried out either under the control of official authority or when the processing is necessary for compliance with a legal or regulatory obligation or collective agreements on the labour market to which a controller is subject , or for the performance of a task carried out for important public interest reasons , and in so far as authorised by union law or member state law providing for adequate safeguards . a complete register of criminal convictions shall be kept only under the control of official authority .


### having regard to the state of the art and the cost of implementation , the controller shall , both at the time of the determination of the means for processing and at the time of the processing itself , implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject . ### having regard to the state of the art , the cost of implementation and international best practices , the controller shall , both at the time of the determination of the means for processing and at the time of the processing itself , implement appropriate measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject .


### right to be forgotten and to erasure ### right to erasure


### where more than one controller or processor is involved in the processing , each controller or processor shall be jointly and severally liable for the entire amount of the damage . ### where more than one controller is involved in the processing , each controller shall be jointly and severally liable for the entire amount of the damage .


### ‘ controller’ means the natural or legal person , public authority , agency or any other body which alone or jointly with others determines the purposes , conditions and means of the processing of personal data ; where the purposes , conditions and means of processing are determined by union law or member state law , the controller or the specific criteria for his nomination may be designated by union law or by member state law ; ### ' controller ' means the natural or legal person , public authority , agency or any other body which alone or jointly with others determines the purposes , of the processing of personal data ; where the purposes of processing are determined by union law or member state law , the controller or the specific criteria for his nomination may be designated by union law or by member state law ;


### a supervisory authority shall in accordance with the consistency mechanism set out in article 58 approve binding corporate rules , provided that they : ### one supervisory authority shall in accordance with the consistency mechanism set out in article 58 and through a single act of approval authorize binding corporate rules for a group of undertakings . those rules will allow multiple intercompany international transfers in and out of europe , provided that they :


### each controller and processor and , if any , the controller ' s representative , shall maintain documentation of all processing operations under its responsibility . ### each controller and , if any , the controller ' s representative , shall maintain documentation of all processing operations under its responsibility .


### every natural person shall have the right not to be subject to a measure which produces legal effects concerning this natural person or significantly affects this natural person , and which is based solely on automated processing intended to evaluate certain personal aspects relating to this natural person or to analyse or predict in particular the natural person ' s performance at work , economic situation , location , health , personal preferences , reliability or behaviour . ### every data subject shall have the right to request not to be subject to a measure which adversely affects this data subject and which is based solely on automated processing of data intended to evaluate , analyse or predict the data subject ' s performance at work , economic situation , location , health , personal preferences , reliability or behaviour .


### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects , in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages or for other reasons , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the european data protection board and to the commission . ### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects , in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the competent supervisory authority , the european data protection board and to the commission .


### ‘ controller’ means the natural or legal person , public authority , agency or any other body which alone or jointly with others determines the purposes , conditions and means of the processing of personal data ; where the purposes , conditions and means of processing are determined by union law or member state law , the controller or the specific criteria for his nomination may be designated by union law or by member state law ; ### ‘ controller’ means the natural or legal person , public authority , agency or any other body which alone or jointly with others determines the purposes of the processing of personal data ; where the purposes of processing are determined by union law or member state law , the controller or the specific criteria for his nomination may be designated by union law or by member state law ;


### in the case of a personal data breach , the controller shall without undue delay and , where feasible , not later than 24 hours after having become aware of it , notify the personal data breach to the supervisory authority . the notification to the supervisory authority shall be accompanied by a reasoned justification in cases where it is not made within 24 hours . ### in the case of a personal data breach relating to special categories of personal date , personal data which are subject to professional secrecy , personal data relating to criminal offences or to the suspicion of a criminal act or personal data relating to bank or credit card accounts , which seriously threaten the rights or legitimate interests of the data subject , the controller shall without undue delay notify the personal data breach to the supervisory authority .


### ‘ representative’ means any natural or legal person established in the union who , explicitly designated by the controller , acts and may be addressed by any supervisory authority and other bodies in the union instead of the controller , with regard to the obligations of the controller under this regulation ; ### ‘ representative’ means any natural or legal person established in the union who , explicitly designated by the controller , acts and shall be addressed by the competent supervisory authority , with regard to the obligations of the controller under this regulation ;


### to monitor the implementation and application of this regulation , in particular as to the requirements related to data protection by design , data protection by default and data security and to the information of data subjects and their requests in exercising their rights under this regulation ; ### to monitor in compliance with the regulation ;


### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects , in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages or for other reasons , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the european data protection board and to the commission . ### in exceptional circumstances , where a supervisory authority considers that there is an urgent need to act in order to protect the interests of data subjects within their territory , when the danger exists that the enforcement of a right of a data subject could be considerably impeded by means of an alteration of the existing state or for averting major disadvantages , by clear breach or unjustified inaction of the competent supervisory authority , by way of derogation from the procedure referred to in article 58 , it may immediately adopt provisional measures with a specified period of validity . the supervisory authority shall , without delay , communicate those measures , with full reasons , to the competent supervisory authority , the european data protection board , the commission and the controller or processor .


### any person who has suffered damage as a result of an unlawful processing operation or of an action incompatible with this regulation shall have the right to receive compensation from the controller or the processor for the damage suffered . ### any person who has suffered damage as a result of an unlawful processing operation or of an action incompatible with this regulation shall have the right to receive compensation from the controller for the damage suffered .


### the controller shall implement mechanisms for ensuring that , by default , only those personal data are processed which are necessary for each specific purpose of the processing and are especially not collected or retained beyond the minimum necessary for those purposes , both in terms of the amount of the data and the time of their storage . in particular , those mechanisms shall ensure that by default personal data are not made accessible to an indefinite number of individuals . ### such measures and procedures shall : take due account of existing technical standards and regulations in the area of public safety and security follow the principle of technology , service and business model neutrality be based on global industry - led efforts and standards take due account of international developments


### the processing of personal data , revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , and the processing of genetic data or data concerning health or sex life or criminal convictions or related security measures shall be prohibited . ### the processing of personal data , revealing race or ethnic origin , political opinions , religion or beliefs , trade - union membership , significant social problems , private information and the processing of genetic data or data concerning health or sex life or criminal convictions or related security measures shall be prohibited .


### the controller or the processor shall designate a data protection officer for a period of at least two years . the data protection officer may be reappointed for further terms . during their term of office , the data protection officer may only be dismissed , if the data protection officer no longer fulfils the conditions required for the performance of their duties . ### the controller or the processor shall designate a data protection officer for a period of at least two years . the data protection officer may be reappointed for further terms .


### the legitimate interests of a controller may provide a legal basis for processing , provided that the interests or the fundamental rights and freedoms of the data subject are not overriding . this would need careful assessment in particular where the data subject is a child , given that children deserve specific protection . the data subject should have the right to object the processing , on grounds relating to their particular situation and free of charge . to ensure transparency , the controller should be obliged to explicitly inform the data subject on the legitimate interests pursued and on the right to object , and also be obliged to document these legitimate interests . given that it is for the legislator to provide by law the legal basis for public authorities to process data , this legal ground should not apply for the processing by public authorities in the performance of their tasks . ### the legitimate interests of a controller may provide a legal basis for processing , provided that the interests or the fundamental rights and freedoms of the data subject are not overriding . to ensure clarity , the data protection board will set out comprehensive guidelines on what can be defined as ' legitimate interest ' . processing would need careful assessment in particular where the data subject is a child , given that children deserve specific protection . the data subject should have the right to object the processing , on grounds relating to their particular situation and free of charge . to ensure transparency , the controller should be obliged to explicitly inform the data subject on the legitimate interests pursued and on the right to object , and also be obliged to document these legitimate interests . given that it is for the legislator to provide by law the legal basis for public authorities to process data , this legal ground should not apply for the processing by public authorities in the performance of their tasks .


### having regard to the state of the art and the cost of implementation , the controller shall , both at the time of the determination of the means for processing and at the time of the processing itself , implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject . ### having regard to the state of the art , the cost of implementation and international best practices , the controller shall , both at the time of the determination of the means for processing and at the time of the processing itself , implement appropriate measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject .


### the protection of the rights and freedoms of data subjects with regard to the processing of personal data require that appropriate technical and organisational measures are taken , both at the time of the design of the processing and at the time of the processing itself , to ensure that the requirements of this regulation are met . in order to ensure and demonstrate compliance with this regulation , the controller should adopt internal policies and implement appropriate measures , which meet in particular the principles of data protection by design and data protection by default . ### to meet consumer and business expectations around the protection of the rights and freedoms of data subjects with regard to the processing of personal data , appropriate organisational measures may be taken , both at the time of the design of the processing and at the time of the processing itself , to ensure that the requirements of this regulation are met . measures having as an objective to increase consumer information and ease of choice shall be encouraged , based on industry cooperation and favouring innovative solutions , products and services .


### the controller or processor shall ensure that the data protection officer performs the duties and tasks independently and does not receive any instructions as regards the exercise of the function . the data protection officer shall directly report to the management of the controller or the processor . ### the data protection organisation or data protection officer shall perform his or her duties and tasks independently .


### consent should be given explicitly by any appropriate method enabling a freely given specific and informed indication of the data subject ' s wishes , either by a statement or by a clear affirmative action by the data subject , ensuring that individuals are aware that they give their consent to the processing of personal data , including by ticking a box when visiting an internet website or by any other statement or conduct which clearly indicates in this context the data subject ' s acceptance of the proposed processing of their personal data . silence or inactivity should therefore not constitute consent . consent should cover all processing activities carried out for the same purpose or purposes . if the data subject ' s consent is to be given following an electronic request , the request must be clear , concise and not unnecessarily disruptive to the use of the service for which it is provided . ### consent should be given unambiguously by any appropriate method within the context of the product or service being offered enabling a freely given specific and informed indication of the data subject ' s wishes , either by a statement or by a clear affirmative action by the data subject , ensuring that individuals are aware that they give their consent to the processing of personal data , including by ticking a box when visiting an internet website or by any other statement or conduct which clearly indicates in this context the data subject ' s acceptance of the proposed processing of their personal data . silence or inactivity should therefore not constitute consent . consent should cover all processing activities carried out for the same purpose or purposes . if the data subject ' s consent is to be given following an electronic request , the request must be clear , concise and not unnecessarily disruptive to the use of the service for which it is provided .


### micro - enterprises in the social economy which employ persons who have lost their job or which employ disadvantaged persons , including the young . ### micro - enterprises , including those in the social economy , which employ persons who have lost their job or are at risk of losing their job , or which employ disadvantaged persons , including the young .


### the council , on a recommendation from the commission , may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public . ### the council , on a proposal from the commission , may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public .


### when assessing imbalances , account should be taken of their severity , of the degree to which they may be considered unsustainable and of the potential negative economic and financial spillovers to other member states . the economic adjustment capacity and the track record of the member state concerned as regards compliance with earlier recommendations issued under this regulation and other recommendations issued under article 121 of the treaty as part of multilateral surveillance , in particular the broad guidelines for the economic policies of the member states and of the union , should also be considered . ### when assessing imbalances , account should be taken of their severity , of the degree to which they may be considered unsustainable and of the potential negative economic and financial spillovers to other member states . particular attention should be paid to member states with large current - account deficits and low competitiveness . the economic adjustment capacity and the track record of the member state concerned as regards compliance with earlier recommendations issued under this regulation and other recommendations issued under article 121 of the treaty as part of multilateral surveillance , in particular the broad guidelines for the economic policies of the member states and of the union , should also be considered .


### ' imbalances ' means macroeconomic developments which are adversely affecting , or have the potential adversely to affect , the proper functioning of the economy of a member state or of economic and monetary union , or of the union as a whole . ### ' imbalances ' means macroeconomic developments including unsustainable competitiveness trends which persistently reduce internal equilibriums and increase divergences among member states adversely affecting , or having the potential to affect adversely , the proper functioning of the economy of a member state , of economic and monetary union , or of the union as a whole .


### this regulation sets out detailed rules for the detection , prevention and correction of macroeconomic imbalances within the union . ### this regulation sets out detailed rules for the detection , prevention and correction of macroeconomic imbalances and vulnerabilities within the union .


### the council , on a recommendation from the commission , may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public . ### the commission may make a recommendation to the council declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . the recommendation by the commission shall be deemed adopted by the council unless it decides , by qualified majority to reject the recommendation within ten days the commission adopting it . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may make the recommendations public .


### ' imbalances ' means macroeconomic developments which are adversely affecting , or have the potential adversely to affect , the proper functioning of the economy of a member state or of economic and monetary union , or of the union as a whole . ### ' imbalances ' means persistently deteriorating competitiveness and / or other macroeconomic developments which adversely affect , or have the potential to affect adversely the proper functioning of the economy of a member state , of economic and monetary union , or of the union as a whole .


### if macroeconomic imbalances are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances should be timely and should use all available policy instruments under the control of public authorities . it should be tailored to the specific environment and circumstances of the member state concerned and cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation . ### if macroeconomic imbalances or vulnerabilities are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances and vulnerabilities should be timely and should use all available policy instruments under the control of public authorities . it should be tailored to the specific environment and circumstances of the member state concerned and cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation .


### the council , on a recommendation from the commission , may adopt recommendations in accordance with article 121 of the treaty declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public . ### the commission may adopt a recommendation to the council declaring the existence of an excessive imbalance and recommending the member state concerned to take corrective action . the recommendation by the commission shall be deemed adopted by the council unless it decides , by qualified majority to reject the recommendation within ten days of the adoption of the recommendation by the commission . those recommendations shall set out the nature of the imbalances and specify the corrective action to be taken in detail and the deadline within which the member state concerned must take such corrective action . the council may , as provided for in article 121 of the treaty , make its recommendations public .


### ' imbalances ' means macroeconomic developments which are adversely affecting , or have the potential adversely to affect , the proper functioning of the economy of a member state or of economic and monetary union , or of the union as a whole . ### ' imbalances ' means persistently deteriorating competitiveness and / or other macroeconomic developments which are adversely affecting , or have the potential to affect adversely , the proper functioning of the economy of a member state or of economic and monetary union , or of the union as a whole and taking full account of single market requirements .


### if macroeconomic imbalances are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances should be timely and should use all available policy instruments under the control of public authorities . it should be tailored to the specific environment and circumstances of the member state concerned and cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation . ### if macroeconomic imbalances are identified , recommendations should be addressed to the member state concerned to provide guidance on appropriate policy responses . the policy response of the member state concerned to imbalances should be timely and should use all available policy instruments under the control of public authorities and involve all relevant national stakeholders . it should be tailored to the specific environment and circumstances of the member state concerned , be compatible with medium and long - term convergence and the targets included in a union strategy for growth and jobs , upholding the single market , fostering international trade links , increasing competitiveness , and also cover the main economic policy areas , potentially including fiscal and wage policies , labour markets , product and services markets and financial sector regulation .


### the scoreboard shall be made up of an array of macroeconomic and macrofinancial indicators for member states . the commission may set indicative lower or upper thresholds for these indicators to serve as alert levels . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states . ### the scoreboard , made up of an array of indicators for member states shall allow for comparisons between member states and reflect short - term , structural and medium - long term trends . the commission shall set indicative and symmetric lower or upper thresholds for these indicators to serve as alert levels .


### biofuels produced from feedstocks listed in part b of annex ix shall be considered to be twice their energy content ; ### part b of annex ix contains , by way of example , lists of feedstocks , biofuels produced from which shall be considered directly in accordance with their energy content ;


### in order to ensure the long - term competitiveness of bio - based industrial sectors , and in line with the 2012 communication ' innovating for sustainable growth : a bioeconomy for europe ' and the roadmap to a resource efficient europe , promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that gives preference to the use of biomass feedstocks that do not have a high economic value for other uses than biofuels . ### in order to ensure the long - term competitiveness and investment security of bio - based industrial sectors , and in line with the 2012 communication ' innovating for sustainable growth : a bioeconomy for europe ' and the roadmap to a resource efficient europe , promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that promotes resource - efficient use of biomass feedstocks and gives preference to second - generation biofuels . the union’s regional policy and the structural funds should play a significant role in promoting new and innovative biofuels .


### bark , branches , leaves , saw dust and cutter shavings . ### timber harvesting residues , such as bark , branches , crown mass , small - sized wood , leaves , saw dust and cutter shavings .


### feedstocks whose contribution towards the target referred to in article 3 shall be considered to be four times their energy content ### feedstocks whose contribution towards the target referred to in article 3 shall be considered to be twice their energy content all feedstocks based on waste , algae and residues , including the following :


### biomass fraction of mixed municipal waste , but not separated household waste subject to recycling targets under article 11 of directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives . ### biomass fraction of mixed municipal waste , including separated biowaste , but not other separated household waste and waste paper subject to recycling targets under article 11 of directive 2008 / 98 / ec of the european parliament and of the council of 19 november 2008 on waste and repealing certain directives .


### biomass fraction of industrial waste . ### biomass fraction of industrial waste , waste from the retail and wholesale trade and process residues .


### tall oil pitch . ### black liquor and its derivatives , such as crude sulphate soap , lignin , crude tall oil and tall oil pitch .


### training activities for members of the judiciary and judicial staff , such as staff exchanges , workshops , seminars , train - the - trainer events , development of online or other training modules ; ### training activities for members of the judiciary and judicial staff , such as staff exchanges , workshops , seminars , train - the - trainer events , development of online or other training modules , which pay particular attention to issues such as gender equality , women ' s rights and the phenomenon of violence against women . training modules should be designed in close cooperation with civil society organisation and experts and equip professionals with the tools to effectively put eu rights and policies into practice ;


### consequently , it is necessary to provide a framework for the recruitment of high calibre staff in terms of productivity and integrity , drawn on the widest possible geographical basis from among citizens of the member states , and to enable such staff to carry out their duties as effectively and efficiently as possible . ### consequently , it is necessary to provide a framework for the recruitment of high calibre staff in terms of productivity and integrity , drawn on the widest possible geographical basis from among citizens of the member states and with due regard to gender balance , and to enable such staff to carry out their duties as effectively and efficiently as possible .


### for vessels fitted with a vessel monitoring system , member states shall verify , based on a representative sampling , that the information received at the fisheries monitoring centres corresponds to activities recorded in the logbook by using vms data . such cross - checks shall be recorded in computer - readable form for a period of three years . particular emphasis shall be placed on the coherence of area data concerning activities observed in areas where horse mackerel stock boundaries meet , namely ices divisions viiic and ixa , iva and ivb , viie and viid . ### particular emphasis shall also be placed on the coherence of area data concerning activities observed in areas where horse mackerel stock boundaries meet , namely ices divisions viiic and ixa , iva and ivb , viie and viid .


### member states shall carry out with regard to western horse mackerel the administrative cross - checks and data verifications provided for in article 19 of regulation no 2847 / 93 . particular emphasis shall be placed on the possibility of small pelagic species other than horse mackerel being reported as horse mackerel , and vice versa . ### when carrying out the validation of data with regard to western horse mackerel in accordance with article [ . . . ] of council regulation no [ &#8230 ; / . . . ] establishing a community control system for ensuring compliance with the rules of the common fisheries policy , particular emphasis shall be placed on the possibility of small pelagic species other than horse mackerel being reported as horse mackerel , and vice versa .


### in order to fish for western horse mackerel , vessels shall hold a special fishing permit issued in accordance with council regulation no 1627 / 94 of 27&#160 ; june 1994 laying down general provisions concerning special fishing permits . ### in order to fish for western horse mackerel , vessels shall hold a fishing authorisation issued in accordance with article 7 of council regulation no&#160 ; . . . / 2009 establishing a community control system for ensuring compliance with the rules of the common fisheries policy .


### member states shall carry out with regard to western horse mackerel the administrative cross - checks and data verifications provided for in article 19 of regulation no 2847 / 93 . particular emphasis shall be placed on the possibility of small pelagic species other than horse mackerel being reported as horse mackerel , and vice versa . ### when carrying out the validation of data with regard to western horse mackerel in accordance with article 102 of regulation no . . . / 2009 , particular emphasis shall be placed on the possibility of small pelagic species other than horse mackerel being reported as horse mackerel , and vice versa .


### in order to fish for western horse mackerel , vessels shall hold a special fishing permit issued in accordance with council regulation no 1627 / 94 of 27 june 1994 laying down general provisions concerning special fishing permits . ### in order to fish for western horse mackerel , vessels shall hold a special fishing authorisation issued in accordance with article [ . . . ] of council regulation no [ &#8230 ; / . . . ] establishing a community control system for ensuring compliance with the rules of the common fisheries policy .


### in order to enable the provision of specialised services to end - users , providers of content , applications and services and providers of electronic communications to the public shall be free to enter into agreements with each other to transmit the related data volumes or traffic as specialised services with a defined quality of service or dedicated capacity . the provision of specialised services shall not impair in a recurring or continuous manner the general quality of internet access services . ### in order to enable the provision of specialised services to end - users , providers of content , applications and services and providers of electronic communications to the public shall be free to enter into agreements with each other to transmit the related data volumes or traffic within closed electronic communications networks as specialised services with a defined quality of service or dedicated capacity , which are not functionally identical to services available over the public internet access service . the provision of specialised services shall not impair the quality of internet access services . where network capacity is shared between internet access services and specialised services , the provider of these services shall publish clear and unambiguous criteria based on which network capacity is shared .


### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ‘ fin - to - carcass’ ratio is established , however , following processing operations , fins and bodies can be landed in different ports . in such cases the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g ; species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation measures , is hampered . ### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ' fin - to - carcass ' ratio is established . however , the ratio is theoretical , because it is based on the weight ratio of shark fins to whole sharks , while sharks are usually landed ' dressed ' . therefore , shark fins and carcasses cannot be directly compared against the ratio , and monitoring must rely on species - specific conversion factors , complicating enforcement . the ratio is also higher than the average fin - to - carcass weight for some species . furthermore , following processing operations , fins and bodies can be landed in different ports . for these reasons , the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g . species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation and management measures , as well as the enforcement of the regulation and punishment for non - compliance , are hampered .


### – the number and nature of cases of non - compliance detected , including a full identification of the vessel involved . ### – the number and nature of cases of non - compliance detected , including a full identification of the vessel involved and the penalty applied for each case of non - compliance .


### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ‘ fin - to - carcass’ ratio is established , however , following processing operations , fins and bodies can be landed in different ports . in such cases the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g ; species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation measures , is hampered . ### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ' fin - to - carcass ' ratio is established . serious control and enforcement difficulties occur with the use of ' fin - to - carcass ' ratio systems . such systems do not eliminate the practice of high - grading and , due to differences in fin cutting techniques and variability of the fin size and weight of different shark species , they could allow finning to occur without being detected . following processing operations , fins and bodies can be landed in different ports . under these circumstances , the collection of data , e . g . species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation and management measures , is hampered .


### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken . ### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that , within the limits of its respective activities , the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken .


### to contribute to the scrutiny of certain conformity assessments pursuant to article 44 ; ### to regularly monitor technical progress , in particular for class iii implantable medical devices ;


### summary of safety and clinical performance in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 . ### safety and clinical performance report in the case of devices submitted for marketing authorisation procedure , other than custom - made or investigational devices , the manufacturer shall draw up a report on the safety and clinical performance of the device based on the full information collected during the clinical investigation . the manufacturer shall also draw up a summary of that report which shall be written in a way that is easy for a lay person to understand . the draft of this report shall be part of the documentation to be submitted to and validated by the national authority or the agency , as relevant , involved in the marketing authorisation procedure . . 1a . the summary referred to in paragraph 1 shall be made available to the public via eudamed in accordance with provisions under article 27 and annex v , part a , point 18 . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in both the report and the summary referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 .


### the manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device . ### the manufacturer of an implantable device shall provide together with the device information which shall be submitted to the healthcare professional implanting the device who will be responsible for : - submitting this information to the patient ; and - recording this information in the patient ' s medical records .


### 2 . 6 . the personnel responsible for carrying out audits of the manufacturer ' s quality management system shall have the following proven qualification : ### 2 . 6 . auditor : the personnel responsible for carrying out audits of the manufacturer ' s quality assurance system shall have the following proven qualification :


### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing phthalates . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for these patient groups and , if applicable , on appropriate precautionary measures . ### shall not contain , in a concentration of 0 . 1% or above by mass per homogeneous material , substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , or substances identified as endocrine disrupters pursuant to the first subparagraph , unless the manufacturer can show that there are no suitable safer substances or devices without these substances . where the manufacturer can show that there are no suitable safer substances or devices without these substances , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b or substances identified as endocrine disrupters . the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for patients and , if applicable , on appropriate precautionary measures .


### this paragraph shall not apply to manufacturers of custom - made devices who are micro - enterprises as defined by commission recommendation 2003 / 361 / ec . ### this paragraph shall not apply to manufacturers of custom - made devices who are registered pharmacies , or micro - enterprises as defined by commission recommendation 2003 / 361 / ec


### members of the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . upon request , the declaration of interests shall be accessible to the public . this article shall not apply to the representatives of stakeholder organisations participating in the sub - groups of the mdcg . ### members of the mdcg , of the advisory panels to the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . the declaration of interests shall be made publicly available on the european commission web site .


### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . ### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a report on the safety and clinical information collected during the clinical investigation and a summary written in a way that is comprehensive and easy to understand . the draft of this report shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . the summary of the safety and clinical performance report should be made publicly available via the european databank as set in article 27 .


### 4 . the devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device . special attention shall be given to substances which are carcinogenic , mutagenic or toxic to reproduction , in accordance with part 3 of annex vi to regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures , amending and repealing directives 67 / 548 / eec and 1999 / 45 / ec , and amending regulation no 1907 / 2006 , and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in article 59 of regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals . ### 4 . the devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device . special attention shall be given to substances which are carcinogenic , mutagenic or toxic to reproduction , in accordance with part 3 of annex vi to regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures , amending and repealing directives 67 / 548 / eec and 1999 / 45 / ec , and amending regulation no 1907 / 2006 , and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health or which are identified in accordance with the procedure set out in article 59 of regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals , or are known or presumed endocrine disrupters pursuant to commission recommendation on criteria for the identification of endocrine disrupters .


### for high - risk medical devices , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available . ### for high - risk medical devices , manufacturers should provide the national authority or the agency , as relevant , involved in the marketing authorisation procedure , with a full report on the safety and clinical performance of that device . a summary of that report should be publicly available via eudamed .


### 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . ### 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data or the evaluation of an assessment made by a subcontractor . .


### summary of safety and clinical performance ### safety and clinical performance report


### the data shall be entered into eudamed by the member states , notified bodies , economic operators and sponsors as specified in the provisions concerning the electronic systems referred to in paragraph 2 . ### the data shall be entered into eudamed by the agency , the member states , notified bodies , economic operators , sponsors and healthcare professionals as specified in the provisions concerning the electronic systems referred to in paragraph 2 .


### all devices incorporating or consisting of nanomaterial are in class iii unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user ' s body when the device is used within its intended purpose . ### all devices incorporating or consisting of nanomaterial deliberately intended to be released into the body are in class iii .