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


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


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


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


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


### where basic acts adopted before the entry into force of this regulation provide for the exercise of implementing powers by the commission in accordance with decision 1999 / 468 / ec , the following rules shall apply : references to article 3 of decision 1999 / 468 / ec shall be understood as references to article 4 of this regulation ; references to articles 4 and 5 of decision 1999 / 468 / ec shall be understood as references to article 5 of this regulation ; references to article 6 of decision 1999 / 468 / ec shall be understood as references to article 6 of this regulation ; references to articles 7 and 8 of decision 1999 / 468 / ec shall be understood as references to article 8 of this regulation . ### pending the adaptation of basic acts adopted before the entry into force of this regulation in accordance with article 9a , where such acts provide for the exercise of implementing powers by the commission in accordance with decision 1999 / 468 / ec , the following rules shall apply : where the basic act makes reference to article 3 of decision 1999 / 468 / ec , the advisory procedure referred to in article 4 of this regulation shall apply ; where the basic act makes reference to articles 4 and 5 of decision 1999 / 468 / ec , the examination procedure referred to in article 5 of this regulation shall apply ; where the basic act makes reference to article 6 of decision 1999 / 468 / ec , article 6 of this regulation shall apply ; where the basic act makes reference to articles 7 and 8 of decision 1999 / 468 / ec , article 8 of this regulation shall apply .


### article 10 adaptation of existing basic acts where basic acts adopted before the entry into force of this regulation provide for the exercise of implementing powers by the commission in accordance with decision 1999 / 468 / ec , the following rules shall apply : references to article 3 of decision 1999 / 468 / ec shall be understood as references to article 4 of this regulation ; references to articles 4 and 5 of decision 1999 / 468 / ec shall be understood as references to article 5 of this regulation ; references to article 6 of decision 1999 / 468 / ec shall be understood as references to article 6 of this regulation ; references to articles 7 and 8 of decision 1999 / 468 / ec shall be understood as references to article 8 of this regulation . 2 . articles 3 and 7 of this regulation shall apply to all existing committees . ### article 10 transitional provisions : adaptation of existing basic acts where basic acts adopted before the entry into force of this regulation provide for the exercise of implementing powers by the commission in accordance with decision 1999 / 468 / ec , the following rules shall apply : where the basic act makes reference to article 3 of decision 1999 / 468 / ec , the advisory procedure referred to in article 4 of this regulation shall apply ; where the basic act makes reference to articles 4 and 5 of decision 1999 / 468 / ec , the examination procedure referred to in article 5 of this regulation shall apply ; where the basic act makes reference to article 4 of decision 1999 / 468 / ec , the second and third subparagraphs of article 5 shall not apply ; where the basic act makes reference to article 5 of decision 1999 / 468 / ec , that basic act shall be considered to be the basic act within the meaning of the second subparagraph , second indent of article 5 ; where the basic act makes reference to article 6 of decision 1999 / 468 / ec , article 6 of this regulation shall apply ; where the basic act makes reference to articles 7 and 8 of decision 1999 / 468 / ec , articles 8 and 8a of this regulation shall apply . 2 . articles 3 and 7 of this regulation shall apply to all existing committees for the purposes of paragraph 1 . 2a . article 5b of this regulation shall apply only to existing procedures which make reference to article 4 of decision 1999 / 468 / ec . 2b . the transitional provisions laid down in this article shall not prejudge the nature of the acts concerned .


### decision 1999 / 468 / ec should be repealed . in order to ensure the transition between the regime provided for in decision 1999 / 468 / ec and this regulation , any reference in existing legislation to the procedures provided for in that decision should , with the exception of the regulatory procedure with scrutiny provided for in article 5a thereof , be understood as a reference to the corresponding procedures provided for in this regulation . the effects of article 5a of decision 1999 / 468 / ec should be maintained for the purposes of existing basic acts which refer to that article . ### decision 1999 / 468 / ec should be repealed . in order to ensure the transition between the regime provided for in decision 1999 / 468 / ec and this regulation , any reference in existing legislation to the procedures provided for in that decision should , with the exception of the regulatory procedure with scrutiny provided for in article 5a thereof , be understood as a reference to the corresponding procedures provided for in this regulation . the transitional measures laid down in article 10 should not prejudge the nature of the acts concerned . the effects of article 5a of decision 1999 / 468 / ec should be provisionally maintained for the purposes of existing basic acts which refer to that article .


### criteria should be laid down to determine the procedure to be used for the adoption of implementing acts . in order to achieve greater consistency and in order to ensure that procedural requirements are proportionate to the nature of the implementing acts to be adopted , those criteria should be binding . ### without prejudice to the procedure to be used for the adoption of implementing acts , which is determined in the basic act , the examination procedure should in principle be used for the adoption of general implementing measures , where uniform conditions are needed .


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


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


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


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


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


### ' conferred powers and committee procedures ' ### ' delegated powers '


### ' 2 . member states shall provide that reporting shall be carried out at least twice a year . the competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . in order to ensure uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , language and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . ### ' 2 . member states shall provide that reporting shall be carried out at least twice a year . the competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , it language and dates of reporting . in order to ensure consistent harmonisation and uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , it language and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities .


### ' 11 . in order to ensure uniform application of this directive , the european insurance and occupational pension authority shall develop draft technical standards listing for each member state provisions of prudential nature relevant to the field of occupational pension schemes which are not covered by the reference to national social and labour law in paragraph 1 . the authority shall submit those draft technical standards to the commission by 1 january 2014 . ### ' 11 . in order to ensure consistent harmonisation and uniform application of this directive , the european insurance and occupational pension authority shall develop draft technical standards listing for each member state provisions of prudential nature relevant to the field of occupational pension schemes which are not covered by the reference to national social and labour law in paragraph 1 . the authority shall submit those draft technical standards to the commission by 1 january 2014 .


### the regulations establishing the esfs provide for a mechanism to settle disagreements between competent national authorities . where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in areas where the relevant legislation requires cooperation , coordination or joint decision making by competent national authorities from more than one member state , the european supervisory authorities , at the request of one of the competent authorities concerned , may assist the authorities in reaching an agreement within the time limit set by the european supervisory authority which takes into account any relevant time limits in the relevant legislation , and the urgency and complexity of the disagreement . in the event that such disagreement persists , the european supervisory authorities may settle the matter . ### the regulations establishing the esfs provide for a mechanism to settle disagreements between competent national authorities . where a competent authority disagrees with the procedure or content of an action or inaction by another competent authority in areas specified in union legislation in accordance with regulation . . . / . . . [ eba ] , regulation . . . / . . . [ esma ] and regulation . . . / . . . [ eiopa ] , where the relevant legislation requires cooperation , coordination or joint decision making by competent national authorities from more than one member state , the european supervisory authorities , at the request of one of the competent authorities concerned , may assist the authorities in reaching an agreement within the time limit set by the european supervisory authority which takes into account any relevant time limits in the relevant legislation , and the urgency and complexity of the disagreement . in the event that such disagreement persists , the european supervisory authorities may settle the matter .


### ' for the communication of these calculations by credit institutions , competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . in order to ensure uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , languages and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] ' . ### ' for the communication of these calculations by credit institutions , competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , it language and dates of reporting . reporting must be able to be done in any official language of the european union . in order to ensure consistent harmonisation and uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , it language and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] ' .


### in order to ensure uniform application of this article , the european banking authority shall develop draft technical standards to determine the conditions of application of this article and a common risk assessment procedure . the authority shall submit those draft technical standards to the commission by 1 january 2014 . ### in order to ensure uniform application of this article , the european banking authority shall develop draft technical standards to determine the conditions of application of this article and a common risk assessment procedure and methodology . the authority shall submit those draft technical standards to the commission by 1 january 2014 .


### member states shall provide that reporting shall be carried out at least twice a year . the competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . in order to ensure uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , language and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] ### member states shall provide that reporting is to be carried out at least twice a year . the competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . the commission is empowered to adopt , by means of delegated acts in accordance with article 290 of the treaty on the functioning of the european union , technical standards to introduce , within the european union , uniform formats , frequencies , language and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the delegation of powers shall last for five years from the date of entry into force of directive 2010 / . . . . / eu on . . . . and shall be extended for periods of five years on a request from the commission made at the latest three months before the expiry of the delegation , unless the european parliament or the council objects to such an extension before the expiry of the delegation . notwithstanding the foregoing , the european parliament or the council may revoke the delegation of powers at any time . a delegated act adopted pursuant to this article shall enter into force only if no objection has been expressed by the european parliament or the council within a period of three months . the commission may adopt the technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] .


### ' in order to ensure uniform application of this article , the european banking authority , in consultation with the european securities and market authority , shall develop draft technical standards to determine the conditions of application of the assessment methodology relating to credit assessments . the authority shall submit those draft technical standards to the commission by 1 january 2014 . ### ' in order to ensure consistent harmonisation and uniform application of this article , the european banking authority , in consultation with the european securities and market authority , shall develop draft technical standards to specify the assessment methodology relating to credit assessments . the authority shall submit those draft technical standards to the commission by 1 january 2014 .


### ' the decision on the application of articles 123 and 124 and article 136 shall be taken by the respective competent authorities responsible for supervision of subsidiaries of an eu parent credit institution or an eu parent financial holding company on an individual or sub - consolidated basis after duly considering the views and reservations expressed by the consolidating supervisor . if , at the end of the four month period , the consolidating supervisor has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities shall await any decision that the european banking authority shall take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ' ### ' the decision on the application of articles 123 and 124 and article 136 shall be taken by the respective competent authorities responsible for supervision of subsidiaries of an eu parent credit institution or an eu parent financial holding company on an individual or sub - consolidated basis after duly considering the views and reservations expressed by the consolidating supervisor . if , at the end of the four month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities shall defer their decision and await any decision that the european banking authority shall take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with union law , and shall take its final decision in conformity with the authority ' s decision . the authority ' s decision according to the precautionary principle shall not replace the consolidating supervisor ' s additional prudential judgement . the four month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . '


### if , at the end of the six month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the six month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the six month period or after a joint decision has been reached ### if , at the end of the six - month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer its decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation on its decision , and shall take its decision in conformity with the european banking authority ' s decision . the six - month period shall be deemed to be the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the six - month period or after a joint decision has been reached . decisions taken by the european banking authority shall not replace the lawful exercise of judgment by the competent authorities of the consolidating supervisor pursuant to this directive .


### ' in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ' ### ' in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer their decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with union law , and shall take its final decision in conformity with the authority ' s decision . the authority ' s decision according to the precautionary principle shall not replace the consolidating supervisor ' s additional prudential judgement . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . '


### ' for the communication of these calculations by credit institutions , competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , language and dates of reporting . in order to ensure uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , languages and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] ' . ### ' for the communication of these calculations by credit institutions , competent authorities shall apply , from 31 december 2012 , uniform formats , frequencies , it language and dates of reporting . in order to consistent harmonisation and ensure uniform application of the directive , the european banking authority shall develop draft technical standards to introduce , within the community , uniform formats , frequencies , it languages and dates of reporting before 1 january 2012 . the reporting formats shall be proportionate to the nature , scale and complexity of the credit institutions ' activities . the commission may adopt the draft technical standards referred to in the first subparagraph in accordance with the procedure laid down in article 7 of regulation . . . / . . . . [ eba ] ' .


### the european council , in its conclusions of 19 june 2009 , recommended that a european system of financial supervisors , comprising three new european supervisory authorities , be established . the system should be aimed at upgrading the quality and consistency of national supervision , strengthening oversight of cross border groups and establishing a european single rule book applicable to all financial institutions in the internal market . it emphasised that the european supervisory authorities should also have supervisory powers for credit rating agencies and invited the commission to prepare concrete proposals on how the european system of financial supervisors could play a strong role in crisis situations . ### the european council , in its conclusions of 19 june 2009 , recommended that a european system of financial supervisors , comprising three new european supervisory authorities , be established . the system should be aimed at upgrading the quality and consistency of national supervision , strengthening oversight of cross border groups , establishing a european single rule book applicable to all financial institutions in the internal market and ensuring adequate harmonisation of criteria and methodology to be applicable by the national supervisors to assess the risk of credit institutions . it emphasised that the european supervisory authorities should also have supervisory powers for credit rating agencies and invited the commission to prepare concrete proposals on how the european system of financial supervisors could play a strong role in crisis situations .


### purchased from separate traders through linked online booking processes where the traveller ' s name or particulars needed to conclude a booking transaction are transferred between the traders at the latest when the booking of the first service is confirmed ; ### purchased from separate traders through linked online booking processes where the traveller’s name or other reservation data needed to conclude a booking transaction are transferred between the traders ;


### insofar as international conventions binding the union limit the extent of or the conditions under which compensation is to be paid by a provider carrying out a service which is part of a package , the same limitations shall apply to the organiser . insofar as international conventions not binding the union limit compensation to be paid by a service provider , member states may limit compensation to be paid by the organiser accordingly . in other cases , the contract may limit compensation to be paid by the organiser as long as that limitation does not apply to personal injury and damage caused intentionally or with gross negligence and does not amount to less than three times the total price of the package . ### insofar as international conventions binding the union limit the extent of or the conditions under which compensation is to be paid by a provider carrying out a service which is part of a package , the same limitations shall apply to the organiser and / or retailer . insofar as international conventions not binding the union limit compensation to be paid by a service provider , member states may limit compensation to be paid by the organiser and / or retailer accordingly .


### general information on passport and visa requirements , including approximate periods for obtaining visas , for nationals of the member state concerned and information on health formalities ; ### general information on passport and visa requirements , as well as any other formalities or requirements concerning identification and movement that may be applicable to travellers , including approximate periods for obtaining visas , for nationals of the member state concerned and information on health formalities ;


### it should also be clarified that contracts by which a trader entitles the traveller after the conclusion of the contract to choose among a selection of different types of travel services , such as in the case of a package travel gift box , should constitute a package . moreover , a combination of travel services should be considered as a package where the traveller ' s name or particulars needed to conclude the booking transaction are transferred between the traders at the latest when the booking of the first service is confirmed . particulars needed to conclude a booking transaction relate to credit card details or other information necessary to obtain a payment . on the other hand , the mere transfer of particulars such as the travel destination or travel times should not be sufficient . ### it should also be clarified that contracts by which a trader entitles the traveller after the conclusion of the contract to choose among a selection of different types of travel services , such as in the case of a package travel gift box , should constitute a package . moreover , a combination of travel services should be considered as a package where the traveller’s name or booking data are transferred between the traders . particulars needed to conclude a booking transaction relate to credit card details or other information necessary to obtain a payment . on the other hand , the mere transfer of particulars such as the travel destination or travel times should not be sufficient .


### if any of the services are not performed in accordance with the contract , the organiser shall remedy the lack of conformity , unless this is disproportionate . ### if any of the services are not performed in accordance with the contract , the organiser shall remedy the lack of conformity .


### if any of the services are not performed in accordance with the contract , the organiser shall remedy the lack of conformity , unless this is disproportionate . ### if any of the services are not performed in accordance with the contract , the organiser and , where applicable on account of the parts they manage respectively , the retailer or the carrier shall remedy the lack of conformity .


### member states shall ensure that prices are not subject to revision , unless the contract expressly reserves the possibility of an increase and obliges the organiser to reduce prices to the same extent as a direct consequence of changes : ### the prices laid down in the contract shall not be subject to revision unless the contract expressly provides for the possibility of upward or downward revision and states precisely how the revised price is to be calculated , and solely to allow for variations in : - transportation costs , including the cost of fuel ; - dues , taxes or fees chargeable for certain services , such as landing taxes or embarkation or disembarkation fees at ports and airports ; - the exchange rates applied to the particular package .


### the price increase referred to in paragraph 1 shall be valid only if the organiser notifies the traveller of it with a justification and calculation on a durable medium at the latest 20 days prior to the start of the package . ### the price increase referred to in paragraph 1 shall be valid only if the organiser notifies the traveller of it with a justification and calculation on a durable medium at the latest 30 days prior to the start of the package .


### member states shall ensure that organisers and retailers facilitating the procurement of assisted travel arrangements established in their territory obtain a security for the effective and prompt refund of all payments made by travellers and , insofar as carriage of passengers is included , for the travellers ' effective and prompt repatriation in the event of insolvency . ### member states shall ensure that organisers , retailers and other operators facilitating the procurement of assisted travel arrangements established in their territory obtain a security for the effective and prompt refund of all payments made by travellers and , insofar as carriage of passengers is included , for the travellers ' effective and prompt repatriation in the event of insolvency .


### member states shall recognise as meeting the requirements of their national rules transposing article 15 any insolvency protection obtained by an organiser or a retailer facilitating the procurement of assisted travel arrangements under the rules of its member state of establishment transposing article 15 . ### member states shall recognise as meeting the requirements of their national rules transposing article 15 any insolvency protection obtained by an operator facilitating the procurement of assisted travel arrangements under the rules of its member state of establishment transposing article 15 .


### if a member state has doubts about the insolvency protection of an organiser or of a retailer facilitating the procurement of assisted travel arrangements which is established in a different member state and is operating on its territory , it shall seek clarification from the member state of establishment . member states shall respond to requests from other member states at the latest within 15 working days of receiving them . ### if a member state has doubts about the insolvency protection of an operator facilitating the procurement of assisted travel arrangements which is established in a different member state and is operating on its territory , it shall seek clarification from the member state of establishment . « member states shall respond to requests from other member states at the latest within 15 working days of receiving them . .


### insofar as international conventions binding the union limit the extent of or the conditions under which compensation is to be paid by a provider carrying out a service which is part of a package , the same limitations shall apply to the organiser . insofar as international conventions not binding the union limit compensation to be paid by a service provider , member states may limit compensation to be paid by the organiser accordingly . in other cases , the contract may limit compensation to be paid by the organiser as long as that limitation does not apply to personal injury and damage caused intentionally or with gross negligence and does not amount to less than three times the total price of the package . ### insofar as international conventions binding the union limit the extent of or the conditions under which compensation is to be paid by a provider carrying out a service which is part of a package , the same limitations shall apply to the organiser . insofar as international conventions not binding the union limit compensation to be paid by a service provider , member states may limit compensation to be paid by the organiser accordingly .


### member states shall ensure that organisers and retailers facilitating the procurement of assisted travel arrangements established in their territory obtain a security for the effective and prompt refund of all payments made by travellers and , insofar as carriage of passengers is included , for the travellers ' effective and prompt repatriation in the event of insolvency . ### member states shall ensure that organisers and retailers facilitating the procurement of packages and assisted travel arrangements obtain a security for the effective and prompt refund of all payments made by travellers and , insofar as carriage of passengers is included , for the travellers ' effective and prompt repatriation in the event of insolvency .


### the central contact points shall make available to each other all necessary information on their national insolvency protection schemes and the identity of the body or bodies providing insolvency protection for a particular trader established in their territory . they shall grant each other access to any inventory listing organisers and retailers facilitating the procurement of assisted travel arrangements which are in compliance with their insolvency protection obligations . ### the central contact points shall make available to each other all necessary information on their national insolvency protection schemes and the identity of the body or bodies providing insolvency protection for a particular trader established in their territory . they shall grant each other access to any inventory listing organisers and retailers facilitating the procurement of packages and assisted travel arrangements which are in compliance with their insolvency protection obligations .


### whether access for persons with reduced mobility is guaranteed throughout the trip or holiday ; ### upon request , whether access for persons with reduced mobility is guaranteed throughout the trip or holiday ;


### member states shall ensure that a traveller may , after giving the organiser reasonable notice on a durable medium before the start of the package , transfer the contract to a person who satisfies all the conditions applicable to that contract . ### member states shall ensure that a traveller may , after giving the organiser and / or the retailer reasonable notice on a durable medium before the start of the package , transfer the contract to a person who satisfies all the conditions applicable to that contract .


### the location , main features and tourist category of the accommodation ; ### the location , main features and tourist category of the accommodation conferred by the competent body in the place where the accommodation is located .


### purchased from separate traders through linked online booking processes where the traveller ' s name or particulars needed to conclude a booking transaction are transferred between the traders at the latest when the booking of the first service is confirmed ; ### purchased from separate traders through linked online booking processes where the traveller’s name or other reservation data needed to conclude a booking transaction are transferred between the traders ;


### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities . ### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on small , medium and large projects with clear eu added value while aiming at ensuring that the administrative burden is at the lowest possible level for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through allowing the possibility of shifting funds between the axes of the programme .


### the remaining 5% shall be apportioned among the axes on an annual basis in line with policy priorities . ### in order to make effective use of funds , an adequate level of flexibility in shifting funds between the axes shall be ensured .


### council presidency events , conferences and seminars ; ### only those council presidency events , conferences and seminars directly responding to the goals of the programme .


### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , in particular children , the elderly and the disabled . ### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics , composition and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , and in particular children , the elderly and the disabled .


### by way of derogation from paragraph 1 , it shall be permitted to fish with trawls , demersal seines or similar gears provided that : ### by way of derogation from paragraph 1 , it shall be permitted to fish with fixed nets , trawls , demersal seines or similar gears provided that :


### improving market access and developing trade , investment and business opportunities for european companies by means of economic partnerships and business and regulatory cooperation . this objective shall be measured by the union’s share in foreign trade with key partner countries and by trade and investments flows to partner countries specifically targeted by actions , programmes and measures under this regulation ; ### improving market access and developing trade , eliminating barriers to trade and investment and combating unjustified protectionist measures , offering a secure investment environment and new business opportunities for european companies worldwide by means of economic partnerships and business and regulatory cooperation . this objective shall be measured by the union’s share in foreign trade with key partner countries and by trade and investments flows to all partner countries specifically targeted by actions , programmes and measures under this regulation ;


### five years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices . ### two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices .


### after the expiry of 35 days after the validation date referred to in paragraph 4 , unless the member state concerned has notified the sponsor within that period of its refusal based on considerations of public health , patient safety or public policy . ### after the expiry of 60 days after the validation date referred to in paragraph 4 , unless the member state concerned has notified the sponsor within that period of its refusal based on considerations of public health , patient safety or public policy .


### the traceability of in vitro diagnostic medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of in vitro diagnostic medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase - policy and stock - management by hospitals . ### the traceability of in vitro diagnostic medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of in vitro diagnostic medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase - policy and stock - management by hospitals , pharmacies and in wholesale . the udi system should be compatible with other systems which are already on the market .


### devices classified as class d in accordance with the rules set out in annex vii , even if manufactured and used within a single health institution , shall comply with the requirements of this regulation . however , the provisions regarding ce marking set out in article 16 and the obligations referred to in articles 21 to 25 shall not apply to those devices . ### devices classified as class d in accordance with the rules set out in annex vii , if manufactured and used within a single health institution , shall be exempt from the requirements of this regulation , with the exception of article 59 and general safety performance requirements set out in annex 1 where the following conditions are met : the recipient patient or patient group ' s specific needs can not be met by an available ce - marked device ; the health institution is accredited to iso standard 15189 quality management system , or any other equivalent recognised standard ; the health institution provides the competent authority referred to in article 26 with a list of such devices , which shall include a justification of their manufacturing , modification or use , in particular , where similar devices have been made available on the market . this information shall be made public . member states shall retain the right to restrict the in - house manufacture and use of any specific type of in - vitro diagnostic device in relation to aspects that are not covered by this regulation , and may also make the manufacture and use of the devices concerned subject to further safety requirements .


### devices classified as class d in accordance with the rules set out in annex vii , even if manufactured and used within a single health institution , shall comply with the requirements of this regulation . however , the provisions regarding ce marking set out in article 16 and the obligations referred to in articles 21 to 25 shall not apply to those devices . ### devices classified as class d in accordance with the rules set out in annex vii , if manufactured and used within a single health institution , shall be exempt from the requirements of this regulation , with the exception of article 59 , where the following conditions are met ; the recipient patient or patient group ' s specific needs can not be met by an available ce - marked device ; the health institution is accredited to en iso standard 15189 quality management system , or any other equivalent recognised standard ; the health institution provides their competent authority referred to in article 26 with a list of such devices , which shall include a justification of their manufacturing or modification , in particular , where similar devices have been made available on the market . this information shall be updated yearly , and shall be made public .


### ' sponsor ' means any individual , company , institution or organisation which takes responsibility for the initiation and management of a clinical performance study ; ### ' sponsor ' means any individual , company , institution or organisation which takes responsibility for the initiation , management , conduct or financing of a clinical performance study ;


### in order to ensure a smooth transition to the registration of in vitro diagnostic medical devices , of relevant economic operators and of certificates , the obligation to submit the relevant information to the electronic systems put in place by this regulation at union level should become fully effective only 18 months after the date of application of this regulation . during this transitional period , article 10 and points and of article 12 of directive 98 / 79 / ec should remain in force . however , economic operators and notified bodies who register in the relevant electronic systems provided for at union level should be considered in compliance with the registration requirements adopted by the member states pursuant to those provisions of the directive to avoid multiple registrations . ### in order to ensure a smooth transition to the registration of in vitro diagnostic medical devices the electronic systems put in place by this regulation at union level should become operational as soon as possible . economic operators and notified bodies who register in the relevant electronic systems provided for at union level should be considered in compliance with the registration requirements adopted by the member states pursuant to those provisions of the directive to avoid multiple registrations .


### where the member state has not notified the sponsor according to paragraph 2 within three days following receipt of the comments or of the completed application , the clinical performance study shall be considered as falling within the scope of this regulation and the application shall be considered complete . ### where the member state has not notified the sponsor according to paragraph 2 within seven days following receipt of the comments or of the completed application , the clinical performance study shall be considered as falling within the scope of this regulation and the application shall be considered complete .


### ‘ companion diagnostic’ means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy ; ### ‘ companion diagnostic’ means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a specific therapy ;


### the sponsor of a clinical performance study shall submit an application to the member state in which the study is to be conducted accompanied by the documentation referred to in annex xiii . within six days after receipt of the application , the member state concerned shall notify the sponsor whether the clinical performance study falls within the scope of this regulation and whether the application is complete . ### the sponsor of a clinical performance study shall submit an application to the member state in which the study is to be conducted accompanied by the documentation referred to in annex xiii . within 14 days after receipt of the application , the member state concerned shall notify the sponsor whether the clinical performance study falls within the scope of this regulation and whether the application is complete .


### where no harmonised standards exist or where relevant harmonised standards are not sufficient , the commission shall be empowered to adopt common technical specifications in respect of the general safety and performance requirements set out in annex i , the technical documentation set out in annex ii or the clinical evidence and post - market follow - up set out in annex xii . the cts shall be adopted by means of implementing acts in accordance with the examination procedure referred to in article 84 . ### where no harmonised standards exist or where there is a need to address public health concerns , the commission shall be empowered to adopt common technical specifications in respect of the general safety and performance requirements set out in annex i , the technical documentation set out in annex ii or the clinical evidence and post - market follow - up set out in annex xii . the cts shall be adopted by means of implementing acts in accordance with the examination procedure referred to in article 84 .


### keep the technical documentation , the eu declaration of conformity and , if applicable , a copy of the relevant certificate , including any supplement , issued in accordance with article 43 at the disposal of competent authorities for the period referred to in article 8 ; ### keep available the summary of technical documentation or on request the technical documentation , the eu declaration of conformity and , if applicable , a copy of the relevant certificate , including any supplement , issued in accordance with article 43 at the disposal of competent authorities for the period referred to in article 8 ;


### this regulation shall not affect national laws which require that certain devices may only be supplied on a medical prescription . ### this regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription . direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal . the following devices may only be supplied on a medical prescription : class d devices 2 ) class c devices in the following categories : devices for genetic testing ; companion diagnostics . the commission shall be empowered to adopt delegated acts in accordance with article 85 to decide on other category c tests after consultation with stakeholders .


### a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study , in natural sciences , medicine , pharmacy , engineering or another relevant discipline , and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices ; ### a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study , in natural sciences , medicine , pharmacy , engineering or another relevant discipline ;


### sanctions for member states whose currency is the euro in the preventive part of the stability and growth pact should provide incentives for prudent fiscal policy - making . such policy - making should ensure that the growth rate of government expenditure does not normally exceed a prudent medium - term growth rate of gross domestic product , unless the excess is matched by increases in government revenues or discretionary revenue reductions are compensated by reductions in expenditure . ### incentives and sanctions for member states whose currency is the euro in the preventive part of the stability and growth pact should ensure prudent fiscal policy - making . such policy - making should ensure that the growth rate of government expenditure does not normally exceed a prudent medium - term growth rate of gross domestic product , unless the excess is matched by increases in government revenues or discretionary revenue reductions are compensated by reductions in expenditure .


### additional sanctions are necessary to make the enforcement of budgetary surveillance more effective in the euro area . those sanctions should enhance the credibility of the fiscal surveillance framework of the union . ### additional incentives and sanctions are necessary to make the enforcement of budgetary surveillance more effective in the euro area . those incentives and sanctions should enhance the credibility of the fiscal surveillance framework of the union .


### if the council decides in accordance with article 126 of the treaty that the member state has not taken effective action in response to a council recommendation within the period laid down , the council , acting on a proposal from the commission , shall decide that the member state shall pay a fine . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 tfeu that the member state has not taken effective action in response to a council recommendation within the period laid down , the council , acting on a proposal from the commission and after consulting the european parliament , while taking due account of account of article 9 tfeu , in particular with regard to the promotion of a high level of employment , the guarantee of adequate social protection and the fight against social exclusion and of the union ' s growth and jobs objectives , shall decide that the member state shall pay a fine . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### a possibility should be provided for the council to reduce or to cancel the sanctions imposed on member states whose currency is the euro on the basis of a commission proposal following a reasoned request by the member state concerned . in the corrective part of the stability and growth pact , the commission should also be able to propose to reduce the size of a sanction or to cancel it on grounds of exceptional economic circumstances . ### a possibility should be provided for the council to reduce or to cancel the sanctions imposed on member states whose currency is the euro on the basis of a commission proposal following a reasoned request by the member state concerned . in the corrective part of the stability and growth pact , the commission should also be able to propose to reduce the size of a sanction or to cancel it on grounds of exceptional economic or social circumstances .


### the interest earned by the commission on deposits lodged in accordance with article 4 and the fines collected in accordance with article 5 shall constitute other revenue referred to in article 311 of the treaty , and shall be distributed , in proportion to their share in the gross national income of the eligible member states , among member states whose currency is the euro which do not have an excessive deficit as determined in accordance with article 126 of the treaty and which are not the subject of an excessive imbalance procedure within the meaning of regulation no [ … / … ] . ### the interest earned by the commission on deposits lodged in accordance with article 4 and the fines collected in accordance with article 5 shall constitute other revenue referred to in article 311 tfeu , and shall be used in support of achieving the union’s long - term investment and jobs objectives .


### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 of the treaty , propose to reduce the amount of the non - interest - bearing deposit or to cancel it . ### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic or social circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 tfeu , propose to reduce the amount of the non - interest - bearing deposit or to cancel it .


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


### if the council addresses to a member state a recommendation in accordance with article 121 of the treaty to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council addresses to a member state a recommendation in accordance with article 121 tfeu to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission and after consulting the european parliament . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### ' tour operator ' means an organiser , other than a carrier , within the meaning of article 2 and of directive 90 / 314 / eec ; ### ' tour operator ' means an organiser , other than a carrier , within the meaning of article 2 of directive 90 / 314 / eec ;


### ' carrier ' means a natural or legal person offering transport by passenger services or cruises to the general public ; ### ' carrier ' means a natural or legal person , other than a tour operator , travel agent or ticket vendor , offering transport by passenger services or cruises to the general public ;


### in order to permit adaptation to technical and scientific progress of directive 2009 / 28 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the list of biofuel feedstocks that are counted multiple times towards the target set in article 3 , the energy content of transport fuels , criteria and geographic ranges for determining highly biodiverse grassland , the methodology for the calculation of indirect land - use change emissions , and the methodological principles and values necessary for assessing whether sustainability criteria have been fulfilled in relation to biofuels and bioliquids . ### in order to permit adaptation to technical and scientific progress of directive 2009 / 28 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the energy content of transport fuels , criteria and geographic ranges for determining highly biodiverse grassland , the methodology for the calculation of the amount of biomass not causing any indirect land - use change emissions , and the methodological principles and values necessary for assessing whether sustainability criteria have been fulfilled in relation to biofuels and bioliquids .


### ' 7 . the commission shall be empowered to adopt delegated acts pursuant to article 10a concerning the adaptation to technical and scientific progress of annex iv , including by the addition of values for further biofuel production pathways for the same or for other raw materials and by modifying the methodology laid down in part c . ' ### ' 7 . the commission shall be empowered to adopt delegated acts pursuant to article 10a concerning the adaptation to technical and scientific progress of annex iv , including by the addition of values for further biofuel production pathways for the same or for other raw materials . '


### paragraph 4 is amended as follows : in point , the following phrase is added : ' this indent shall be without prejudice to articles 17a and 3d ; ' the following point is added : for the calculation of biofuels in the numerator , the share of energy from biofuels produced from cereal and other starch rich crops , sugars and oil crops shall be no more than 5% , the estimated share at the end of 2011 , of the final consumption of energy in transport in 2020 . ### paragraph 4 is amended as follows : the first sentence is replaced by the following : each member state shall ensure that the share of energy from renewable sources in all forms of transport in 2020 is at least 10 % of the final consumption of energy in transport in that member state , in point , the following phrase is added : ' this indent shall be without prejudice to articles 17a and 3d ; ' the following point is added : for the calculation of biofuels in the numerator , the share of energy from biofuels produced from feedstock listed in annex ix shall be at least 2% of the final consumption of energy in transport in 2020 , and the share of energy from biofuels produced from food crops shall be at least 8% of the final consumption of energy .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . conventional biofuels , such as those made from wastes , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . advanced biofuels , such as those made from cellulosic feedstocks and algae , have the potential to provide high greenhouse gas savings with low risk of causing indirect land use change . it is appropriate , therefore , to encourage greater production of such advanced biofuels . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels by establishing a separate 2% target for advanced biofuels .


### 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 of bio - based industrial sectors , and to provide a stable regulatory environment for existing and new investments , 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 , a commitment should be made that the levels of biofuels encouraged by directive 2009 / 28 / ec will be maintained in the subsequent years after 2020 .


### member states may not maintain or introduce , in their national law , provisions diverging from those laid down in this directive , including more or less stringent provisions to ensure a different level of consumer protection . ### unless indicated differently in this directive , member states may adopt or maintain in force more stringent provisions , compatible with the treaty in the field covered by this directive , to ensure a higher level of consumer protection . 2 . where member states maintain or introduce more stringent provisions to ensure a higher level of consumer protection in the field harmonised by this directive , these provisions must be compatible with the treaty and must be notified to the commission . the commission shall make that information public on a website or in another easily accessible way . 3 . the rights resulting from this directive shall be exercised without prejudice to other rights which the consumer may invoke under the national rules governing contractual or non - contractual liability .


### the deployment and exploitation phases of the galileo programme and the exploitation phase of the egnos programme should , in principle , be entirely financed by the union . however in accordance with regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities , the member states should be able to provide additional funding to the programmes or a contribution in kind , on the basis of appropriate agreements , in order to fund additional programme elements requested by them , e . g . concerning the system architecture or particular security needs . third countries and international organisations should also be able to contribute to the programmes . ### the deployment and exploitation phases of the galileo programme and the exploitation phase of the egnos programme should , in principle , be entirely financed by the union . however in accordance with regulation no xxx / 2012 of the european parliament and of the council of . . . 2012 on [ the financial rules applicable to the annual budget of the union ] , the member states should be able to provide additional funding to the programmes or a contribution in kind , on the basis of appropriate agreements , in order to fund additional programme elements requested by them , e . g . concerning the system architecture or particular security needs . third countries and international organisations should also be able to contribute to the programmes in accordance with the principle of mutual interest .


### in order to guarantee the continuation of the programmes , an appropriate financial framework must be established to allow the union to continue to finance them . it is also necessary to indicate the amount of money required between 1 january 2014 to 31 december 2020 to finance completion of the deployment phase of the galileo programme and operation of the systems . ### given the long lead times involved and the levels of capital investment already committed to these projects , sufficient and consistent financial commitments over financial planning periods are required in order to ensure the planning continuity and organisational stability of the programmes . in order to guarantee the continuation of the programmes , an appropriate financial framework must be established to allow the union to continue to finance them . it is also necessary to specify the maximum amount of money required between 1 january 2014 to 31 december 2020 to finance completion of the deployment phase of the galileo programme and operation of the systems .


### the hlg noted that the dairy producing and processing sectors are highly differentiated between member states . there is also a highly variable situation between operators and types of operators within individual member states . but concentration of supply is low in many cases with a resulting imbalance in bargaining power in the supply chain between farmers and dairies . this imbalance can lead to unfair commercial practices ; in particular , farmers do not know what price they will receive for their milk when delivering because the price is often fixed much later by dairies on a basis of the obtained added value , which , for non - cooperatives , is often outside of the farmer ' s control . ### the hlg also noted that the dairy producing and processing sectors are highly differentiated between member states . there is thus a highly variable situation between operators and types of operators within individual member states . but concentration of demand is high in most cases while that of supply is low , with a resulting imbalance in bargaining power in the supply chain between producers and processors . this imbalance can lead to unfair commercial practices ; in particular , farmers often do not know what price they will receive for their milk upon delivery as the price is often fixed much later by dairies on a basis of the obtained added value , which , for non - cooperatives , is often outside of the farmer’s control .


### the hlg noted that the dairy producing and processing sectors are highly differentiated between member states . there is also a highly variable situation between operators and types of operators within individual member states . but concentration of supply is low in many cases with a resulting imbalance in bargaining power in the supply chain between farmers and dairies . this imbalance can lead to unfair commercial practices ; in particular , farmers do not know what price they will receive for their milk when delivering because the price is often fixed much later by dairies on a basis of the obtained added value , which , for non - cooperatives , is often outside of the farmer ' s control . ### the hlg noted that the dairy producing and processing sectors are highly differentiated between member states . there is also a highly variable situation between operators and types of operators within individual member states . but concentration of supply is low in many cases with a resulting imbalance in bargaining power in the supply chain between farmers and dairies . this imbalance can lead to unfair commercial practices ; in particular , farmers often do not know what price they will receive for their milk upon delivery as the price is often fixed much later by dairies on a basis of the obtained added value , which is generally outside farmers’ control , often whether or not they belong to a cooperative .


### in 2007 - 2009 , exceptional developments took place in milk and milk products sector markets . initially , extreme weather conditions in oceania brought about a significant decline in supplies , leading to a rapid and significant increase in prices . yet while world supplies had started their recovery , and prices had started to return to more normal levels , the subsequent financial and economic crisis negatively affected eu dairy producers , aggravating price volatility . initially feed and other input costs including energy increased significantly as a result of higher commodity prices . subsequently , a drop in worldwide , as well as eu , demand , including for milk and milk products , whilst eu production was stable led to a collapse in eu prices , down to the lower safety net level . this sharp decline in dairy commodity prices failed to fully translate into lower dairy prices at consumer levels , generating a widening in the gross margin of the downstream sectors for most milk and milk sector products and countries , and preventing demand for them to adjust to low commodity prices , slowing down price recovery and exacerbating the impact of low prices on milk producers . ### in 2007 - 2009 , exceptional developments took place in the milk and milk products sector markets , and had an unprecedented impact on the industry’s activity in europe . initially , extreme weather conditions in oceania brought about a significant decline in supplies , leading to rapid and significant increase in prices . yet while world supplies had started their recovery , and prices had started to return to more normal levels , the subsequent financial and economic crisis negatively affected eu dairy producers , aggravating price volatility . initially feed and other input costs including energy increased significantly as a result of higher commodity prices . subsequently , a drop in worldwide , as well as eu , demand , including for milk and milk products , whilst eu production was stable led to a collapse in eu prices , down to the lower safety net level . this sharp decline in dairy commodity prices failed to fully translate into lower dairy prices at consumer levels , generating a widening in the gross margin of the downstream sectors for most milk and milk sector products and countries . this prevented demand for them from adjusting to low commodity prices , slowing down price recovery and exacerbating the impact of low prices on milk producers , putting a substantial number of them in an inextricable financial situation .


### the hlg obtained oral and written input from major european stakeholder groups in the dairy supply chain representing farmers , dairy processors , dairy traders , retailers and consumers . further , the hlg received contributions from invited academic experts , third country representatives , national competition authorities and the commission ' s services . a dairy stakeholder conference was also held on 26 march 2010 allowing a wider range of actors in the supply chain to express their views . the hlg delivered its report on 15 june 2010 , which contained an analysis of the current situation of the dairy sector and number of recommendations . ### the hlg obtained oral and written input from major european stakeholder groups in the dairy supply chain and delivered its report on 15 june 2010 . the report contained an analysis of the current situation of the dairy sector and a number of recommendations which focused on contractual relations , the bargaining power of producers , interprofessional / interbranch organisations , transparency , market measures and futures , marketing standards and origin labelling and innovation and research .


### in october 2009 , in light of this difficult market situation for milk , a high level expert group on milk was set up with the purpose of discussing mid - term and long - term arrangements for the milk and milk products sector , given the expiry of dairy quotas in 2015 . while respecting the outcome of the health check , the hlg was to work on a regulatory framework to be put in place , to contribute to stabilising the market and producers ' income and enhance its transparency . ### in october 2009 , in response to the alarming situation facing european milk producers , a high level expert group on milk was set up ; its purpose was discussing mid - term and long - term arrangements for the milk and milk products sector designed to cushion the adverse effects of the expiry of dairy quotas and work on a regulatory framework to be put in place , to contribute to stabilising the market and producers’ income and enhance the sector’s transparency .


### member states shall ensure that fees , if any , applied by the transferring or the receiving payment service provider to the consumer for any service provided under article 10 , other than those referred to in paragraphs 1 to 3 , shall be appropriate and in line with the actual costs of that payment service provider . ### member states shall ensure that no fees are applied by the transferring or the receiving payment service provider to the consumer for any service provided under article 10 .