### information on a vehicle’s performance in terms of co2 emissions and fuel consumption should be made publicly available to enable all vehicle operators to take well - informed purchasing decisions . all vehicle manufacturers will be able to compare their vehicles’ performance with those of other makes . this will increase the incentives for innovation and therefore increase competitiveness . that information will also provide policy makers at union and member state level with a sound basis for developing policies to promote the uptake of more energy - efficient vehicles . it is therefore appropriate that the co2 emissions and fuel consumption values determined for each new heavy - duty vehicle pursuant to commission regulation [ … / … ] 15 [ opoce to include correct reference ] are monitored , reported to the commission and made available to the public . __________________ 15 commission regulation [ … / … ] implementing regulation no 595 / 2009 of the european parliament and of the council as regards the determination of co2 emissions and fuel consumption of heavy - duty vehicles and amending directive 2007 / 46 / ec of the european parliament and of the council and commission regulation no 582 / 2011 . ### information on a vehicle’s performance in terms of co2 emissions and fuel consumption should be made publicly available to enable all vehicle operators to take well - informed purchasing decisions . all vehicle manufacturers will be able to compare their vehicles’ performance with those of other makes . this will increase the incentives for innovation and therefore increase competitiveness . that information will also provide policy makers at union and member state level with a sound basis for developing policies to promote the uptake of more energy - efficient vehicles . making necessary information publicly available or available to third parties upon request will allow stakeholders to perform independent verification testing and conduct market research and comparison . this will increase the reliability of the vecto tool and spur innovation and competitiveness . it is therefore appropriate that the co2 emissions and fuel consumption values determined for each new heavy - duty vehicle pursuant to commission regulation [ … / … ] 15 [ opoce to include correct reference ] are monitored , reported to the commission and made available to the public . __________________ 15 commission regulation [ … / … ] implementing regulation no 595 / 2009 of the european parliament and of the council as regards the determination of co2 emissions and fuel consumption of heavy - duty vehicles and amending directive 2007 / 46 / ec of the european parliament and of the council and commission regulation no 582 / 2011 .


### technical data essential for determining the co2 emissions and fuel consumption performance of a vehicle should be publicly available to increase the transparency of the vehicle specifications and the related performance , and to foster competition among manufacturers . only data that are sensitive on the grounds of personal data protection and fair competition should not be published . however , it is clearly in the public interest that technical data essential for determining the performance of vehicles is available . such data should therefore not be exempt from public access . ### technical data essential for determining the co2 emissions and fuel consumption performance of a vehicle should be publicly available to increase the transparency of the vehicle specifications and the related performance , and to foster competition among manufacturers . only data that are sensitive on the grounds of personal data protection and fair competition should not be published and should only be considered where necessary . however , it is clearly in the public interest that technical data essential for determining the performance of vehicles is available . such data should therefore not be exempt from public access .


### in order to acquire a complete knowledge on the configuration of the heavy - duty vehicle fleet in the union , its development over time and potential impact on co2 emissions , it is appropriate to monitor and report data on the registration of all new heavy - duty vehicles and all new trailers , including data on the powertrains as well as the relevant bodywork . ### in order to acquire a complete knowledge on the configuration of the heavy - duty vehicle fleet in the union , its development over time and potential impact on co2 emissions , it is appropriate to monitor and report and make publicly available in a digitally searchable format and free of charge the data on the registration of all new heavy - duty vehicles and all new trailers , including the data on the efficiency of powertrains as well as the relevant bodywork and components .


### the commission may carry out its own verification of the quality of the data reported pursuant to articles 4 and 5 . ### the commission shall carry out its own verification of the quality of the data , on a representative sample and on a regular basis , reported pursuant to articles 4 and 5 .


### technical data essential for determining the co2 emissions and fuel consumption performance of a vehicle should be publicly available to increase the transparency of the vehicle specifications and the related performance , and to foster competition among manufacturers . only data that are sensitive on the grounds of personal data protection and fair competition should not be published . however , it is clearly in the public interest that technical data essential for determining the performance of vehicles is available . such data should therefore not be exempt from public access . ### technical data essential for determining the co2 emissions and fuel consumption performance of a vehicle should be publicly available to increase the transparency of the vehicle specifications and the related performance , and to foster competition among manufacturers . only data that are sensitive on the grounds of personal data protection and fair competition should not be published . however , it is clearly in the public interest that technical data essential for determining and evaluating the performance of vehicles is available . such data should therefore not be exempt from public access .


### the commission shall keep a central register for the data reported in accordance with articles 4 and 5 . the register shall be publicly available with the exception of data entries 1 , 24 , 25 , 32 , 33 , 39 and 40 specified in part b of annex i . ### the commission shall keep a central register for the data reported in accordance with articles 4 and 5 . the register shall be publicly available with the exception of sensitive data in entry 1 of part b of annex i and commercially important data relating to entries 23 , 24 , 25 , 32 , 33 , 39 and 40 specified in part b of annex i . the latter shall be disclosed on request .


### the commission shall publish the total number of allowances in circulation each year , by 15 may of the subsequent year . the total number of allowances in circulation for year x shall be the cumulative number of allowances issued in the period since 1 january 2008 , including the number issued pursuant to article 13 of directive 2003 / 87 / ec in that period and entitlements to use international credits exercised by installations under the eu emission trading system in respect of emissions up to 31 december of year x , minus the cumulative tonnes of verified emissions from installations under the eu emission trading system between 1 january 2008 and 31 december of year x , any allowances cancelled in accordance with article 12 of directive 2003 / 87 / ec and the number of allowances in the reserve . no account shall be taken of emissions during the three - year period starting in 2005 and ending in 2007 and allowances issued in respect of those emissions . the first publication shall take place by 15 may 2017 . ### the commission shall publish the total number of allowances in circulation each year , by 15 may of the subsequent year . the total number of allowances in circulation for year x shall be the cumulative number of allowances issued in the period since 1 january 2008 , including the number issued pursuant to article 13 of directive 2003 / 87 / ec in that period and entitlements to use international credits exercised by installations under the eu emission trading system in respect of emissions up to 31 december of year x , minus the cumulative tonnes of verified emissions from installations under the eu emission trading system between 1 january 2008 and 31 december of year x , any allowances cancelled in accordance with article 12 of directive 2003 / 87 / ec and the number of allowances in the reserve . no account shall be taken of emissions during the three - year period starting in 2005 and ending in 2007 and allowances issued in respect of those emissions . the first publication shall take place by 15 may 2016 .


### “1 . from 2021 onwards , member states shall auction all allowances that are not allocated free of charge in accordance with article 10a and 10c and are not placed in the market stability reserve established by decision [ opeu please insert number of this decision when known ] of the european parliament and of the council . ” ### “1 . from 1 july 2016 onwards , member states shall auction all allowances that are not allocated free of charge in accordance with article 10a and 10c , are not placed in the market stability reserve established by decision [ opeu please insert number of this decision when known ] of the european parliament and of the council”


### in each year beginning in 2021 , a number of allowances equal to 12% of the total number of allowances in circulation in year x - 2 , as published in may year x - 1 , shall be placed in the reserve , unless this number of allowances to be placed in the reserve would be less than 100 million . ### by 30 june of each year beginning in 2017 , a number of allowances equal to 33% of the total number of allowances in circulation in year x - 1 , as published in may year x , minus 833 million shall be placed in the reserve .


### in each year beginning in 2021 , a number of allowances equal to 12% of the total number of allowances in circulation in year x - 2 , as published in year x - 1 , shall be placed in the reserve , unless this number of allowances to be placed in the reserve would be less than 100 million . ### in each year beginning in 2021 , a number of allowances equal to 12% of the total number of allowances in circulation in year x - 1 , as published in may year x , shall be placed in the reserve , unless this number of allowances to be placed in the reserve would be less than 100 million .


### where the volume of allowances to be auctioned by member states in the last year of each period referred to in article 13 exceeds by more than 30% the expected average auction volume for the first two years of the following period before application of article 1 of decision [ opeu please insert number of this decision when known ] , two - thirds of the difference between the volumes shall be deducted from auction volumes in the last year of the period and added in equal instalments to the volumes to be auctioned by member states in the first two years of the following period . ### at the end of phase 3 , any allowances remaining in the new entrants ' reserve and any allowances not allocated due to partial cessations , closures or significant capacity reductions shall be considered ' unallocated allowances ' . a volume of allowances equivalent to the total number of unallocated allowances shall be withdrawn from auction in 2020 and cancelled .


### where the volume of allowances to be auctioned by member states in the last year of each period referred to in article 13 exceeds by more than 30% the expected average auction volume for the first two years of the following period before application of article 1 of decision [ opeu please insert number of this decision when known ] , two - thirds of the difference between the volumes shall be deducted from auction volumes in the last year of the period and added in equal instalments to the volumes to be auctioned by member states in the first two years of the following period . ### where the volume of allowances to be auctioned by member states in the last two years of each period referred to in article 13 exceeds by more than 30% the expected auction volumes for the first two years of the following period before application of article 1 of decision [ opeu please insert number of this decision when known ] , two - thirds of the difference between the volumes shall be deducted and retired in equal instalments from auction volumes in the last two years of the period .


### a market stability reserve is established , and shall operate from 1 january 2021 . ### a market stability reserve is established , and shall operate from 1 july 2016 .


### furthermore , in addition to the establishment of the market stability reserve , a few consequential amendments should be made to directive 2003 / 87 / ec to ensure consistency and smooth operation of the ets . in particular , the operation of directive 2003 / 87 / ec may lead to large volumes of allowances to be auctioned at the end of each trading period which can undermine market stability . accordingly , in order to avoid an imbalanced market situation of supply of allowances at the end of one trading period and the beginning of the next with possibly disruptive effects for the market , provision should be made for the auctioning of part of any large increase of supply at the end of one trading period in the first two years of the next period . ### furthermore , in addition to the establishment of the market stability reserve , a few consequential amendments should be made to directive 2003 / 87 / ec to ensure consistency and smooth operation of the ets . in particular , the operation of directive 2003 / 87 / ec may lead to large volumes of allowances to be auctioned at the end of each trading period which can undermine market stability . accordingly , in order to avoid an imbalanced market situation of supply of allowances at the end of one trading period and the beginning of the next with possibly disruptive effects for the market , provision should be made for the cancellation of at least part of any large increase of supply at the end of one trading period .


### the report from the commission to the european parliament and the council on the state of the european carbon market in 21027 identified the need for measures in order to tackle structural supply - demand imbalances . the impact assessment on the 2030 climate and energy policy framework8 indicates that this imbalance is expected to continue , and would not be sufficiently addressed by adapting the linear trajectory to a more stringent target within this framework . a change in the linear factor only changes gradually the cap . accordingly , the surplus would also only gradually decline , such that the market would have to continue to operate for more than a decade with a surplus of around 2 billion allowances or more . in order to address this problem and to make the european emission trading system more resilient to imbalances , a market stability reserve should be established . to ensure regulatory certainty as regards auction supply in phase 3 and allow for some lead - time adjusting to the introduction of the design change , the market stability reserve should be established as of phase 4 starting in 2021 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning in 2021 , allowances corresponding to 12% of the number of allowances in circulation in year x - 2 should be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 400 million . __________________ 7 com 652 final . 8 insert reference . ### to ensure the market stability reserve has a quick and significant impact on the european emissions trading system , a market stability reserve should be established as of 1 july 2016 . without early introduction , projections show that the amount of surplus allowances would not fall below the current levels until 2025 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning as of 1 july 2016 , allowances corresponding to 20% of the number of allowances in circulation in year x - 1 should be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 300 million .


### in each year beginning in 2021 , a number of allowances equal to 12% of the total number of allowances in circulation in year x - 2 , as published in may year x - 1 , shall be placed in the reserve , unless this number of allowances to be placed in the reserve would be less than 100 million . ### by 1 january of each year beginning in 2017 , a number of allowances equal to 20% of the total number of allowances in circulation in year x - 1 as published in may year x , shall be placed in the reserve , unless this number of allowances to be placed in the reserve would be below 167 million .


### “1 . from 2021 onwards , member states shall auction all allowances that are not allocated free of charge in accordance with article 10a and 10c and are not placed in the market stability reserve established by decision [ opeu please insert number of this decision when known ] of the european parliament and of the council . ” ### “1 . from 2016 onwards , member states shall auction all allowances that are not allocated free of charge in accordance with article 10a and 10c and are not placed in the market stability reserve established by decision [ oj : please insert number of this decision ] of the european parliament and of the council . ”


### where the volume of allowances to be auctioned by member states in the last year of each period referred to in article 13 exceeds by more than 30% the expected average auction volume for the first two years of the following period before application of article 1 of decision [ opeu please insert number of this decision when known ] , two - thirds of the difference between the volumes shall be deducted from auction volumes in the last year of the period and added in equal instalments to the volumes to be auctioned by member states in the first two years of the following period . ### where the volume of allowances to be auctioned by member states in the last two years of each period referred to in article 13 exceeds by more than 30% the expected auction volumes for the first two years of the following period before application of article 1 of decision [ opeu please insert number of this decision when known ] , the difference between the volumes shall be deducted and retired in equal instalments from auction volumes in the last two years of the period .


### the report from the commission to the european parliament and the council on the state of the european carbon market in 21021 identified the need for measures in order to tackle structural supply - demand imbalances . the impact assessment on the 2030 climate and energy policy framework2 indicates that this imbalance is expected to continue , and would not be sufficiently addressed by adapting the linear trajectory to a more stringent target within this framework . a change in the linear factor only changes gradually the cap . accordingly , the surplus would also only gradually decline , such that the market would have to continue to operate for more than a decade with a surplus of around 2 billion allowances or more . in order to address this problem and to make the european emission trading system more resilient to imbalances , a market stability reserve should be established . to ensure regulatory certainty as regards auction supply in phase 3 and allow for some lead - time adjusting to the introduction of the design change , the market stability reserve should be established as of phase 4 starting in 2021 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning in 2021 , allowances corresponding to 12% of the number of allowances in circulation in year x - 2 should be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 400 million . __________________ 7 com 652 final . 8 insert reference . ### the report from the commission to the european parliament and the council on the state of the european carbon market in 21021 identified the need for measures in order to tackle structural supply - demand imbalances . the impact assessment on the 2030 climate and energy policy framework2 indicates that this imbalance is expected to continue , and would not be sufficiently addressed by adapting the linear trajectory to a more stringent target within this framework . a change in the linear factor only changes gradually the cap . accordingly , the surplus would also only gradually decline , such that the market would have to continue to operate for more than a decade with a surplus of around 2 billion allowances or more . in order to address this problem and to make the european emission trading system more resilient to imbalances , a market stability reserve should be established during phase 3 , so as to establish the benefits thereof before the launch of phase 4 in 2021 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning in 2017 , allowances corresponding to 12% of the number of allowances in circulation in year x - 1 should therefore be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 400 million . __________________ 7 com0652 . 8 insert reference .


### by 31 december 2026 , the commission shall on the basis of an analysis of the orderly functioning of the european carbon market review the market stability reserve and submit a proposal , where appropriate , to the european parliament and to the council . the review shall pay particular attention to the percentage figure for the determination of the number of allowances to be placed into the reserve according to article 1 and the numerical value of the threshold for the total number of allowances in circulation set by article 1 . ### within three years of the market stability reserve becoming fully operational , the commission shall , on the basis of an analysis of the orderly functioning of the european carbon market , review the market stability reserve and submit a proposal , where appropriate , to the european parliament and to the council . the review shall pay particular attention to the percentage figure for the determination of the number of allowances to be placed into the reserve according to article 1 and the numerical value of the threshold for the total number of allowances in circulation set by article 1 with the aim of determining the effectiveness of the market stability reserve and its proportionality with respect to the impact on sectors at risk of carbon leakage and the situation of households .


### by 31 december 2026 , the commission shall on the basis of an analysis of the orderly functioning of the european carbon market review the market stability reserve and submit a proposal , where appropriate , to the european parliament and to the council . the review shall pay particular attention to the percentage figure for the determination of the number of allowances to be placed into the reserve according to article 1 and the numerical value of the threshold for the total number of allowances in circulation set by article 1 . ### by 31 december 2020 , the commission shall on the basis of an analysis of the orderly functioning of the european carbon market review the market stability reserve and submit a proposal , where appropriate , to the european parliament and to the council .


### the report from the commission to the european parliament and the council on the state of the european carbon market in 21027 identified the need for measures in order to tackle structural supply - demand imbalances . the impact assessment on the 2030 climate and energy policy framework8 indicates that this imbalance is expected to continue , and would not be sufficiently addressed by adapting the linear trajectory to a more stringent target within this framework . a change in the linear factor only changes gradually the cap . accordingly , the surplus would also only gradually decline , such that the market would have to continue to operate for more than a decade with a surplus of around 2 billion allowances or more . in order to address this problem and to make the european emission trading system more resilient to imbalances , a market stability reserve should be established . to ensure regulatory certainty as regards auction supply in phase 3 and allow for some lead - time adjusting to the introduction of the design change , the market stability reserve should be established as of phase 4 starting in 2021 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning in 2021 , allowances corresponding to 12% of the number of allowances in circulation in year x - 2 should be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 400 million . __________________ 7 com652 final . 8 insert reference . ### the report from the commission to the european parliament and the council on the state of the european carbon market in 21027 identified the need for measures in order to tackle structural supply - demand imbalances . the impact assessment on the 2030 climate and energy policy framework8 indicates that this imbalance is expected to continue , and would not be sufficiently addressed by adapting the linear trajectory to a more stringent target within this framework . a change in the linear factor only changes gradually the cap . accordingly , the surplus would also only gradually decline , such that the market would have to continue to operate for more than a decade with a surplus of around 2 billion allowances or more . in order to address this problem and to make the european emission trading system more resilient to imbalances , a market stability reserve should be established . to ensure the market stability reserve has a quick and significant impact on the european emission trading system it should be established as of 2017 . without early establishment of the reserve , projections show that the amount of surplus allowances would not fall below current levels until 2025 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning in 2017 , allowances corresponding to 20% of the number of allowances in circulation in year x - 1 should be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 300 million . __________________ 7 com652 final . 8 insert reference .


### the report from the commission to the european parliament and the council on the state of the european carbon market in 21021 identified the need for measures in order to tackle structural supply - demand imbalances . the impact assessment on the 2030 climate and energy policy framework2 indicates that this imbalance is expected to continue , and would not be sufficiently addressed by adapting the linear trajectory to a more stringent target within this framework . a change in the linear factor only changes gradually the cap . accordingly , the surplus would also only gradually decline , such that the market would have to continue to operate for more than a decade with a surplus of around 2 billion allowances or more . in order to address this problem and to make the european emission trading system more resilient to imbalances , a market stability reserve should be established . to ensure regulatory certainty as regards auction supply in phase 3 and allow for some lead - time adjusting to the introduction of the design change , the market stability reserve should be established as of phase 4 starting in 2021 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning in 2021 , allowances corresponding to 12% of the number of allowances in circulation in year x - 2 should be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 400 million . ____________________ 1 com652 final . 2 insert reference ### the report from the commission to the european parliament and the council on the state of the european carbon market in 21021 identified the need for measures in order to tackle structural supply - demand imbalances . the impact assessment on the 2030 climate and energy policy framework2 indicates that this imbalance is expected to continue , and would not be sufficiently addressed by adapting the linear trajectory to a more stringent target within this framework . a change in the linear factor only changes gradually the cap . accordingly , the surplus would also only gradually decline , such that the market would have to continue to operate for more than a decade with a surplus of around 2 billion allowances or more . in order to address this problem and to make the ets more resilient to supply - demand imbalances , and thus to correct a design error in that system , so as to enable it to function as an orderly market with stable and competitive prices , reflecting the true value of allowances , a market stability reserve should be established . the market stability reserve will also ensure synergies with other climate policies such as those on renewable energy and energy efficiency . to ensure regulatory certainty as regards auction supply in phase 3 and allow for some lead - time adjusting to the introduction of the design change , the market stability reserve should be established as of phase 4 starting in 2021 . in order to preserve a maximum degree of predictability , clear rules should be set for placing allowances into the reserve and releasing them from the reserve . where the conditions are met , beginning in 2021 , allowances corresponding to 12% of the number of allowances in circulation in year x - 1 should be put into the reserve . a corresponding number of allowances should be released from the reserve when the total number of allowances in circulation is lower than 400 million . ____________________ 1 com652 final . 2 insert reference


### “1 . from 2021 onwards , member states shall auction all allowances that are not allocated free of charge in accordance with article 10a and 10c and are not placed in the market stability reserve established by decision [ opeu please insert number of this decision when known ] of the european parliament and of the council . ” ### “1 . from 2017 onwards , member states shall auction all allowances that are not allocated free of charge in accordance with article 10a and 10c and are not placed in the market stability reserve established by decision [ oj : please insert number of this decision ] of the european parliament and of the council . ”


### eurojust ' s competence shall cover the forms of crime listed in annex 1 . however , its competence shall not include the crimes for which the european public prosecutor ' s office is competent . ### until the date when the european public prosecutor ' s office has assumed its investigative and prosecutorial tasks conferred on it in accordance with article 75 of regulation implementing enhanced cooperation on the establishment of the european public prosecutor ' s office , eurojust ' s competence shall cover the criminal offences listed in annex 1 . however , from the date the eppo assumes its tasks , eurojust shall only be competent in cases where the eppo is competent but does not exercise its competence ; where member states which are not participating the eppo seek support from eurojust , and where the eppo itself seeks the support of eurojust .


### the day - to - day administration of eurojust ; ### the day - to - day administration of eurojust and staff management ;


### all the national members when the college exercises its operational functions under article 4 ; ### all the national members ;


### assist the competent authorities of the member states in ensuring the best possible coordination of investigations and prosecutions ; ### ensure the best possible coordination of investigations and prosecutions conducted by the competent authorities of the member states ;


### eurojust’s competence shall cover related criminal offences . the following offences shall be regarded as related criminal offences : ### eurojust’s competence shall cover related criminal offences to the criminal offences laid down in annex 1 . the following offences shall be regarded as related criminal offences :


### the president of the college shall appear before the european parliament , at their request , to discuss matters relating to eurojust , and in particular to present its annual reports , taking into account the obligations of discretion and confidentiality . discussions shall not refer directly or indirectly to concrete actions in relation with specific operational cases . ### before taking office , a newly appointed president of the college shall be invited to make a statement before the competent committee or committees of the european parliament and answer questions put by its or their members . during his or her term of office , he or she shall appear before the european parliament , at their request , to discuss matters relating to eurojust , and in particular to present its annual reports , taking into account the obligations of discretion and confidentiality . discussions shall not refer directly or indirectly to concrete actions in relation with specific operational cases .


### the president of the college shall appear before the european parliament , at their request , to discuss matters relating to eurojust , and in particular to present its annual reports , taking into account the obligations of discretion and confidentiality . discussions shall not refer directly or indirectly to concrete actions in relation with specific operational cases . ### before taking office , the newly appointed president of the college shall be invited to make a statement before the competent committee or committees of the european parliament and answer questions put by its or their members . during his or her term of office , he or she shall appear before the european parliament , at its request , to discuss matters relating to eurojust , and in particular to present its annual reports , taking into account the obligations of discretion and confidentiality . discussions shall not refer directly or indirectly to concrete actions in relation with specific operational cases .


### all the national members and two representatives of the commission when the college exercises its management functions under article 14 . ### and two representatives of the commission when management issues are discussed or measures thereon are adopted .


### the agency shall be responsible for coordinating the existing scientific resources put at its disposal by member states for the evaluation , supervision and pharmacovigilance of medicinal products . ### the second paragraph of article 55 is amended as follows : the agency shall be responsible for coordinating the scientific resources put at its disposal by member states for the evaluation , supervision and pharmacovigilance of medicinal products for human use , as provided for in this regulation , and for veterinary use , as provided for in regulation 2015 / xxx + . ’ ______________ + oj : please , insert the number of regulation in document cod 2014 / 0257 .


### the first subparagraph of article 67 is replaced by the following : ‘ the agency’s revenue shall consist of a contribution from the union , fees paid by undertakings for obtaining and maintaining union marketing authorisations and for other services provided by the agency , or by the coordination group as regards the fulfilment of its tasks in accordance with articles 107c , 107e , 107g , 107k and 107q of directive 2001 / 83 / ec and charges for other services provided by the agency . ’ ### article 67 is replaced by the following : ‘ the agency’s revenue shall consist of : a contribution from the union ; a contribution from any european third country with which the union has concluded agreements ; the fees paid by undertakings for obtaining and maintaining union marketing authorisations for human and veterinary medicinal products and for other services provided by the agency , as provided for in this regulation and in regulation 2015 / xxx + , or by the coordination group as regards the fulfilment of its tasks in accordance with articles 107c , 107e , 107g , 107k and 107q of directive 2001 / 83 / ec ; charges for any other services provided by the agency ; and other sources of income , including any ad - hoc grants within the scope of title vi of regulation no 966 / 2012 of the european parliament and of the council1a . the european parliament and the council shall re - examine , when necessary , the level of the union contribution , referred to in point of the first subparagraph , on the basis of an evaluation of needs and by taking account of the level of fees . ´ ________________ + oj : please , insert the number of regulation in document cod 2014 / 0257 . 1a regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union and repealing council regulation no 1605 / 2002 .


### the delegation of power referred to in articles 3 , 10b , 14 , 16 and 84 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the delegation of power referred to in articles 3 , 10b , 14 , 16 and 84 shall be conferred on the commission for a period of five years from the date of entry into force of this regulation . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the agency’s revenue shall consist of a contribution from the union , fees paid by undertakings for obtaining and maintaining union marketing authorisations and for other services provided by the agency , or by the coordination group as regards the fulfilment of its tasks in accordance with articles 107c , 107e , 107g , 107k and 107q of directive 2001 / 83 / ec and charges for other services provided by the agency . ### the agency’s revenue shall consist of a contribution from the union , fees paid by undertakings for obtaining and maintaining union marketing authorisations for medicinal products for human and veterinary use , and for other services provided by the agency in accordance with this regulation and regulation 2015 / . . . , or by the coordination group as regards the fulfilment of its tasks in accordance with articles 107c , 107e , 107g , 107k and 107q of directive 2001 / 83 / ec and charges for other services provided by the agency .


### present text the executive director shall implement the budget of the agency . 2 . by 1 march at the latest following each financial year , the agency ' s accounting officer shall communicate the provisional accounts to the commission ' s accounting officer together with a report on the budgetary and financial management for that financial year . the commission ' s accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with article 128 of the financial regulation applicable to the general budget of the european communities . 3 . by 31 march at the latest following each financial year , the commission ' s accounting officer shall submit the agency ' s provisional accounts to the court of auditors , together with a report on the budgetary and financial management for that financial year . the report on the budgetary and financial management for the financial year shall also be forwarded to the european parliament and the council . 4 . on receipt of the court of auditors ' observations on the agency ' s provisional accounts , pursuant to article 129 of the general financial regulation , the executive director shall draw up the agency ' s final accounts under his own responsibility and submit them to the management board for an opinion . 5 . the management board of the agency shall deliver an opinion on the agency ' s final accounts . 6 . the executive director shall , by 1 july at the latest following each financial year , forward the final accounts to the european parliament , the council , the commission and the court of auditors , together with the management board ' s opinion . 7 . the final accounts shall be published . 8 . the agency ' s executive director shall send the court of auditors a reply to its observations by 30 september at the latest . he shall also send this reply to the management board . 9 . the executive director shall submit to the european parliament , at the latter ' s request , any information required for the smooth application of the discharge procedure for the financial year in question , as laid down in article 146 of the general financial regulation . 10 . the european parliament , on a recommendation from the council acting by a qualified majority , shall , before 30 april of year n + 2 , give a discharge to the executive director in respect of the implementation of the budget for year n . 11 . the financial rules applicable to the agency shall be adopted by the management board after the commission has been consulted . they may not depart from commission regulation no 2343 / 2002 of 19 november 2002 on the framework financial regulation for the bodies referred to in article 185 of council regulation no 1605 / 2002 on the financial regulation applicable to the general budget of the european communities , unless specifically required for the agency ' s operation and with the commission ' s prior consent . ### article 68 is replaced by the following : ' 1 . the executive director shall implement the budget of the agency . 2 . by 1 march of the following financial year , the agency ' s accounting officer shall send the provisional accounts to the commission ' s accounting officer and to the court of auditors 3 . by 31 march of the following financial year , the executive director shall send the report on the budgetary and financial management to the european parliament , the commission , the council and the court of auditors . 4 . by 31 march of the following financial year , the commission ' s accounting officer shall send the agency ' s provisional accounts , consolidated with the commission ' s provisional accounts , to the court of auditors . on receipt of the court of auditors ' observations on the agency ' s provisional accounts pursuant to article 148 of the financial regulation applicable to the general budget of the union , the accounting officer shall draw up the agency ' s final accounts and the executive director shall submit them to the management board for an opinion . 5 . the management board shall deliver an opinion on the agency ' s final accounts . 6 . the accounting officer shall , by 1 july following each financial year , send the final accounts to the european parliament , the council , the accounting officer of the commission and the court of auditors , together with the management board ' s opinion . 7 . the final accounts shall be published in the official journal of the european union by 15 november of the following year . 8 . the executive director shall send the court of auditors a reply to its observations by 30 september . 9 . the executive director shall submit to the european parliament , at the latter ' s request , any information required for the smooth application of the discharge procedure for the financial year in question , in accordance with article 165 of the financial regulation applicable to the general budget of the union . 10 . on a recommendation from the council , the european parliament shall , before 15 may of year n + 2 , give a discharge to the executive director in respect of the implementation of the budget for year n . 11 . the financial rules applicable to the agency shall be adopted by the management board after the commission has been consulted . they shall not depart from commission delegated regulation no 1271 / 2013 unless specifically required for the agency ' s operation and with the commission ' s prior consent . '


### in order to ensure uniform conditions for the implementation of regulation no 726 / 2004 , implementing powers should be conferred on the commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human use . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council1 . __________________ 1 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers . ### in order to ensure uniform conditions for the implementation of regulation no 726 / 2004 , implementing powers should be conferred on the commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human and veterinary use . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council1 . __________________ 1 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers .


### the executive director shall implement the budget of the agency . 2 . by 1 march at the latest following each financial year , the agency ' s accounting officer shall communicate the provisional accounts to the commission ' s accounting officer together with a report on the budgetary and financial management for that financial year . the commission ' s accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with article 128 of the financial regulation applicable to the general budget of the european communities . 3 . by 31 march at the latest following each financial year , the commission ' s accounting officer shall submit the agency ' s provisional accounts to the court of auditors , together with a report on the budgetary and financial management for that financial year . the report on the budgetary and financial management for the financial year shall also be forwarded to the european parliament and the council . 4 . on receipt of the court of auditors ' observations on the agency ' s provisional accounts , pursuant to article 129 of the general financial regulation , the executive director shall draw up the agency ' s final accounts under his own responsibility and submit them to the management board for an opinion . 5 . the management board of the agency shall deliver an opinion on the agency ' s final accounts . 6 . the executive director shall , by 1 july at the latest following each financial year , forward the final accounts to the european parliament , the council , the commission and the court of auditors , together with the management board ' s opinion . 7 . the final accounts shall be published . 8 . the agency ' s executive director shall send the court of auditors a reply to its observations by 30 september at the latest . he shall also send this reply to the management board . 9 . the executive director shall submit to the european parliament , at the latter ' s request , any information required for the smooth application of the discharge procedure for the financial year in question , as laid down in article 146 of the general financial regulation . 10 . the european parliament , on a recommendation from the council acting by a qualified majority , shall , before 30 april of year n + 2 , give a discharge to the executive director in respect of the implementation of the budget for year n . 11 . the financial rules applicable to the agency shall be adopted by the management board after the commission has been consulted . they may not depart from commission regulation no 2343 / 2002 of 19 november 2002 on the framework financial regulation for the bodies referred to in article 185 of council regulation no 1605 / 2002 on the financial regulation applicable to the general budget of the european communities , unless specifically required for the agency ' s operation and with the commission ' s prior consent . ________________ 21 council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities . 1 22 oj l 357 , 31 . 12 . 2002 , p . 72 . ### article 68 is replaced by the following : ‘ 1 . the executive director shall implement the budget of the agency . 2 . by 1 march at the latest following each financial year , the agency ' s accounting officer shall communicate the provisional accounts to the commission ' s accounting officer . the commission ' s accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with article 147 of regulation no 966 / 2012 . 3 . by 31 march at the latest following each financial year , the commission ' s accounting officer shall submit the agency ' s provisional accounts to the court of auditors , together with a report on the budgetary and financial management for that financial year . the report on the budgetary and financial management for the financial year shall also be forwarded to the european parliament and the council . 4 . on receipt of the court of auditors ' observations on the agency ' s provisional accounts , pursuant to article 148 of the general financial regulation , the accounting officer shall draw up the agency ' s final accounts and the executive director shall submit them to the management board for an opinion . 5 . the management board of the agency shall deliver an opinion on the agency ' s final accounts . 6 . the accounting officer shall , by 1 july of the following financial year , forward the final accounts to the european parliament , the council , the commission and the court of auditors , together with the management board ' s opinion . 7 . the final accounts shall be published . 8 . the agency ' s executive director shall send the court of auditors a reply to its observations by 30 september of the following year at the latest . 9 . the executive director shall submit to the european parliament , at the latter ' s request , any information required for the smooth application of the discharge procedure for the financial year in question , as laid down in article 165 of the general financial regulation . 10 . the european parliament , on a recommendation from the council , shall , before 15 may of year n + 2 , give a discharge to the executive director in respect of the implementation of the budget for year n . 11 . the financial rules applicable to the agency shall be adopted by the management board after the commission has been consulted . they may not depart from commission delegated regulation no 1271 / 20131aunless specifically required for the agency ' s operation and with the commission ' s prior consent . ’ __________________ 1a commission delegated regulation no 1271 / 2013 of 30 september 2013 on the framework financial regulation for the bodies referred to in article 208 of regulation no 966 / 2012 of the european parliament and of the council .


### in article 62 , the second subparagraph is deleted ; ### article 62 is amended as follows : in paragraph 1 , the third subparagraph is replaced by the following : ‘ when consulting the scientific advisory groups referred to in article 56 , the committee shall forward to them the draft assessment report drawn up by the rapporteur or the co - rapporteur . the opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant committee in such a way as to ensure that the deadlines laid down in article 6 of this regulation and in article 40 of regulation 2015 / xxx + are met . ’ ; in paragraph 1 , the fourth subparagraph is replaced by the following : ‘ the substance of the opinion shall be included in the assessment report published pursuant to article 13 of this regulation and article 40 of regulation 2015 / xxx + . ’ ; in paragraph 3 , the second subparagraph is deleted ; ______________ + oj : please , insert the number of regulation in document cod 2014 / 0257 .


### each member state shall , after consultation of the management board , appoint , for a three - year term which may be renewed , one member and one alternate to the committee for medicinal products for human . ### each member state shall , after consultation of the management board , appoint , for a three - year term which may be renewed , one member and one alternate to the committee for medicinal products for human use .


### the commission shall develop and maintain an information and communication system for the collection and storage of information , in a structured form , on issues relating to the enforcement of union harmonisation legislation . the commission , single liaison offices , and authorities designated in accordance with article 26 shall have access to that system . ### the commission shall develop and maintain an information and communication system for the collection , processing and storage of information , in a structured form , on issues relating to the enforcement of union harmonisation legislation with the aim of sharing this data among member states and allow the commission to monitor market surveillance activities . the commission , single liaison offices and authorities designated in accordance with article 26 shall have access to that system .


### the identity and contact details of the person responsible for compliance information with respect to the product shall be indicated on or identifiable from information indicated on the product , its packaging , the parcel or an accompanying document . ### the name , registered trade name or registered trade mark and the contact details , including the postal address , of the person responsible for compliance with respect to the product shall be indicated on the product or , where not possible because of the size or physical characteristics of the product , on its packaging or the accompanying documents .


### member states shall confer on their market surveillance authorities the powers of market surveillance , investigation and enforcement necessary for the application of this regulation and for the application of the union harmonisation legislation set out in the annex to this regulation . ### member states shall confer on their market surveillance authorities the powers of market surveillance , including the market surveillance of products sold online , investigation and enforcement necessary for the application of this regulation and for the application of the union harmonisation legislation set out in the annex to this regulation and shall provide them with the necessary resources in that regard .


### the power to take temporary measures , where there are no other effective means available to prevent a serious risk , including in particular temporary measures requiring hosting service providers to remove , disable or restrict access to content or to suspend or restrict access to a website , service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time ; ### the power to adopt measures , where there are no other effective means available to prevent a serious risk , including in particular measures requiring hosting service providers to remove , disable or restrict access to content or to suspend or restrict access to a website , service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time ;


### market surveillance authorities may enter into memoranda of understanding with businesses or organisations representing businesses or end - users for the carrying out , or financing , of joint activities aimed at identifying non - compliance or promoting compliance in specific geographical areas or with respect to specific categories of product . ### market surveillance authorities may enter into memoranda of understanding with economic operators , or organisations representing economic operators or end - users for the carrying out , or financing , of joint activities aimed at raising awareness , providing advice and guidance in relation to the union harmonisation legislation , promoting voluntary actions , identifying non - compliance or promoting compliance in specific geographical areas or with respect to specific categories of product , including the products sold online .


### each member state shall draw up a national market surveillance strategy , as a minimum , every 3 years . the strategy shall promote a consistent , comprehensive and integrated approach to market surveillance and enforcement of union harmonisation legislation within the territory of the member state and shall include all sectors and stages of the product supply chain , including imports and digital supply chains . ### each member state shall draw up a national market surveillance strategy , as a minimum , every 3 years . the national strategy shall take into account the priorities set out within the work programme of the network established under article 31 and promote a consistent , comprehensive and integrated approach to market surveillance and enforcement of union harmonisation legislation within the territory of the member state , including the market surveillance of products sold online , and shall include all sectors and stages of the product supply chain , including imports and digital supply chains .


### for any other reason , there is cause to believe that the product will not comply with the requirements set out in the union harmonisation legislation applicable to it when it is placed on the market or that it will pose a serious risk . ### for any other reason , there is cause to believe that the product does not comply with the requirements set out in the union harmonisation legislation applicable to it or that it poses a risk .


### the framework for market surveillance should be strengthened , with a view to further improving compliance with and enforcement of union harmonisation legislation on products . ### currently , the implementation of surveillance to guarantee compliance is insufficient . the framework for market surveillance should be strengthened in order to reach the set objectives , with a view to further improving compliance with and enforcement of union harmonisation legislation on products . surveillance of compliance should go beyond monitoring of safety of a product , and cover other eu standards such as labour , health and environmental standards .


### the identity and contact details of a person responsible for compliance information with respect to the product is not indicated or identifiable in accordance with article 4 ; ### the name , registered trade name or registered trade mark and the contact details , including the postal address , of a person responsible for compliance with respect to the product is not indicated or identifiable in accordance with article 4 ;


### market surveillance authorities shall perform controls as part of their activities set out in paragraph 1 , on a risk - based approach , taking into account , as a minimum , the following factors : ### market surveillance authorities shall perform controls as part of their activities set out in paragraph 1 , on a risk - based approach , taking into account the precautionary principle and , as a minimum , the following factors :


### the power to require any public authority , body or agency within the market surveillance authority ' s member state , or any natural or legal person , to provide any information , data or document , in any form or format and irrespective of its storage medium or the place where it is stored , for the purposes of enabling the market surveillance authority to investigate whether any non - compliance has occurred or is occurring and to establish the details of that non - compliance , including in particular information , data or documents required for the purposes of identifying and tracing financial and data flows , ascertaining the identity and contact details of persons involved in financial and data flows and ascertaining bank account information and the ownership of websites ; ### the power to require any public authority , body or agency within the market surveillance authority ' s member state , or any natural or legal person , to provide any information , data or document , in any form or format and irrespective of its storage medium or the place where it is stored , for the purposes of enabling the market surveillance authority to investigate whether any non - compliance has occurred or is occurring and to establish the details of that non - compliance , including in particular information , data or documents required for the purposes of identifying and tracing financial and data flows , ascertaining the identity and contact details of persons involved in financial and data flows and ascertaining bank account information and the ownership of websites , when the information , data or document in question is related to the subject matter of the investigation ;


### market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance related to product safety . ### market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance with the union harmonisation legislation , related to but not limited to product safety , including with general eu standards such as the environment and labour laws .


### cooperating with the market surveillance authorities , at their request , on any action taken to eliminate or , if that is not possible , mitigate the risks posed by the product . ### cooperate with the market surveillance authorities and take immediate action to remedy any case of non - compliance with the requirements set out in union harmonisation legislation applicable to the product in question , at their own initiative or when required to do so by the market surveillance authorities ;


### the nature , gravity and duration of the non - compliance taking into account the harm caused to end - users ; ### the nature , gravity and duration of the non - compliance taking into account the harm caused to end - users or to public interests ;


### a product may be made available on the market only if the following conditions are met : ### a product may be made available on the market only if a contact person that is obliged to the disclosure of information is established in the union . this person is responsible for compliance with respect to the product in question . in this respect manufacturers that are established in a third country are deemed to be considered equal to those established in the european union / european economic area .


### market surveillance authorities act in the interest of economic operators , end - users , and of the general public , to ensure that public interests established by union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement action , and that compliance with such legislation is ensured across the supply chain through appropriate controls . consequently , market surveillance authorities should account to economic operators , end - users and the general public for the efficiency and effectiveness of the activities they perform . they should provide access to information concerning the organisation and performance of their activities , including controls , and regularly publish information on activities performed and the results of such activities . they should also , subject to certain conditions , be entitled to publish or to make available information about the compliance record of individual economic operators based on the outcome of market surveillance controls . ### market surveillance authorities act in the interest of economic operators , end - users , and of the general public , to ensure that public interests established by union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement action , and that compliance with such legislation is ensured across the supply chain through appropriate controls . consequently , market surveillance authorities should account to economic operators , end - users and the general public for the efficiency and effectiveness of the activities they perform . they should provide access to information concerning the organisation and performance of their activities , including controls , and regularly publish information on activities performed and the results of such activities . they should also , subject to certain conditions , be entitled to publish or to make available information about the compliance record of individual economic operators based on the outcome of market surveillance controls , particularly in the case of economic operators that have been found to have repeated breaches in compliance with union harmonisation legislation .


### responsibility for enforcing union harmonisation legislation should lie with the member states , whose market surveillance authorities should be required to ensure that the legislation is fully complied with . the member states should , therefore , establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities . ### responsibility for enforcing union harmonisation legislation should lie with the member states , whose market surveillance authorities should be required to ensure that the legislation is fully complied with . the member states should , therefore , establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities . in this regard , member states should monitor their national market surveillance authorities in order to ensure that they fulfill the requirements laid down in this regulation .


### for any other reason , there is cause to believe that the product will not comply with the requirements set out in the union harmonisation legislation applicable to it when it is placed on the market or that it will pose a serious risk . ### for any other reason , there is a reasonable and justified cause to believe that the product does not comply with the requirements set out in the union harmonisation legislation applicable to it with the aim of placing it on the market or that it poses a serious risk .


### the commission shall establish separate or joint administrative coordination groups for all the instruments of union harmonisation legislation listed in the annex to this regulation . each administrative coordination group shall be composed of representatives of the competent national market surveillance authorities and , if appropriate , representatives of the single liaison offices , and representatives of the relevant business associations and of consumer associations . ### the commission shall establish separate or joint administrative coordination groups for all the instruments of union harmonisation legislation listed in the annex to this regulation . each administrative coordination group shall be composed of representatives of the competent national market surveillance authorities and , if appropriate , representatives of the single liaison offices , and representatives of the relevant business associations and of consumer associations . the commission shall organise and attend the meetings of the administrative coordination groups as an observer .


### safety of consumers largely depends on the active enforcement of union harmonisation legislation on products providing for safety requirements . it is therefore necessary to strengthen enforcement measures . these measures should be continuously improved and increasingly effective with a view to meeting the current challenges of a global market and an increasingly complex supply chain . ### safety of consumers largely depends on the active enforcement of union harmonisation legislation on products providing for safety requirements . it is therefore necessary to strengthen enforcement measures , including with regard to the products that are offered for sale online to end - users within the union . these measures should be continuously improved and increasingly effective with a view to meeting the current challenges of a global market and an increasingly complex supply chain .


### the person responsible for compliance information shall perform the following tasks : ### the person responsible for compliance shall have the following responsibilities :


### the taking by them of appropriate and proportionate temporary measures and the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this regulation . ### the taking by them of appropriate and proportionate measures and the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this regulation .


### market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale , by means of documentary checks and , where appropriate , physical and laboratory controls on the basis of a representative sample . ### market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency , by means of documentary checks and , where appropriate , sufficient physical and laboratory controls on the basis of sufficient representative samples .


### this regulation lays down rules and procedures for the provision of compliance information about certain products that are the subject of union acts harmonising the conditions for the marketing of those products . it establishes a framework for cooperation with economic operators in relation to such products . ### it also lays down rules and procedures for the provision of compliance information about certain products that are the subject of union acts harmonising the conditions for the marketing of those products .


### in deciding what checks to perform and on what scale , market surveillance authorities shall take into account , in particular , established principles of risk assessment and complaints . ### in deciding what checks to perform , on what types of products and on what scale , market surveillance authorities shall take into account , in particular , established principles of risk assessment and complaints .


### the identity and contact details of the person responsible for compliance information with respect to the product shall be indicated on or identifiable from information indicated on the product , its packaging , the parcel or an accompanying document . ### the name , registered trade name or registered trade mark and the contact details , including the postal address , of the person responsible for compliance with respect to the product shall be indicated on the product or , where not possible because of the size or physical characteristics of the product , on its packaging or the accompanying documents .


### the commission shall withdraw an approval granted under paragraph 3 where it is revealed that the products entering the union market do not comply with union harmonisation legislation in a significant number of instances . ### the commission shall regularly monitor the correct functioning of the approval and shall withdraw an approval granted under paragraph 3 where it is revealed that the products entering the union market do not comply with union harmonisation legislation in a significant number of instances . the commission shall inform member states and the affected third country .


### market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance related to product safety . ### market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance with the union harmonisation legislation , related to but not limited to product safety , including with general eus standards such as the environment and labour laws .


### a fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition . to this purpose , strengthened enforcement of union harmonisation legislation on products is necessary . good cooperation between manufacturers and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product . it is important that there should be a contact person established in the union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s compliance with union harmonisation legislation . the person responsible for providing such compliance information should be the manufacturer , or the importer , or another person designated by the manufacturer for this purpose , for example another economic operator . the role of a person responsible for compliance information established in the union is essential for providing market surveillance authorities with an interlocutor established in the union , and for performing specific tasks in a timely manner to ensure that the products comply with the requirements of union harmonisation legislation , for the benefit of consumers , workers and businesses within the union . the provisions in this regulation requiring there to be a person established in the union responsible for compliance information should not apply where specific requirements set out in certain legal instruments on products achieve the same result in effect , namely article 4 of regulation no 1223 / 2009 , article 15 of regulation 2017 / 745 and article 15 of regulation 2017 / 746 . ### a fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition . to this purpose , strengthened enforcement of union harmonisation legislation on products is necessary . good cooperation between manufacturers and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product . it is important that there should be a responsible person established in the union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s compliance with union harmonisation legislation and who can take action to remedy instances of non - compliance . the person responsible for compliance should be the manufacturer , or the importer , or another person designated by the manufacturer for this purpose , for example an authorised representative or another economic operator . the role of a person responsible for compliance established in the union is essential for providing market surveillance authorities with an interlocutor established in the union , and for performing specific tasks in a timely manner to ensure that the products comply with the requirements of union harmonisation legislation , for the benefit of consumers , workers and businesses within the union . the provisions in this regulation requiring there to be a person established in the union responsible for compliance should not apply where specific requirements set out in certain legal instruments on products achieve the same result in effect , namely article 4 of regulation no 1223 / 2009 , article 15 of regulation 2017 / 745 and article 15 of regulation 2017 / 746 .


### the powers conferred on market surveillance authorities under paragraph 1 shall include the following powers as a minimum : ### the powers conferred on market surveillance authorities under paragraph 1 shall include at least the following powers :


### the report shall assess whether this regulation achieved its objectives , in particular with regard to reducing the number of non - compliant products on the union market , ensuring effective and efficient enforcement of union harmonisation legislation within the union , improving cooperation between competent authorities and strengthening the controls on products entering the union market , whilst taking into account the impact on business and in particular on small and medium - sized enterprises . in addtion , the evaluation should also assess the effectiveness of the market surveillance activities that receive union financing in the light of the requirements of union policies and legislation . ### the report shall assess whether this regulation achieved its objectives , in particular with regard to reducing the number of non - compliant products on the union market , ensuring effective and efficient enforcement of union harmonisation legislation within the union , improving cooperation between competent authorities and strengthening the controls on products entering the union market , whilst taking into account the impact on business and in particular on small and medium - sized enterprises . the evaluation shall be carried out , in particular , with a view to assessing the scope of this regulation , as well as the effectiveness of the provisions of this regulation with regard to internet of things and artificial intelligence enabled devices and in light of technological , economic and legal developments . the evaluation should also assess the effectiveness of the market surveillance activities that receive union financing in the light of the requirements of union policies and legislation .


### the identity and contact details of a person responsible for compliance information with respect to the product is not indicated or identifiable in accordance with article 4 ; ### the name , registered trade name or registered trade mark and the contact details , including the postal address , of a person responsible for compliance with respect to the product is not indicated or identifiable in accordance with article 4 ;


### the nature of the temporary measures taken by them against economic operators and of the corrective action taken by economic operators ; ### the details of the measures taken by them against economic operators , commitments given to them by economic operators and the details of the corrective action taken by economic operators ;


### person responsible for compliance information ### person responsible for compliance


### the report shall assess whether this regulation achieved its objectives , in particular with regard to reducing the number of non - compliant products on the union market , ensuring effective and efficient enforcement of union harmonisation legislation within the union , improving cooperation between competent authorities and strengthening the controls on products entering the union market , whilst taking into account the impact on business and in particular on small and medium - sized enterprises . in addtion , the evaluation should also assess the effectiveness of the market surveillance activities that receive union financing in the light of the requirements of union policies and legislation . ### the report shall assess whether this regulation achieved its objectives , in particular with regard to reducing the number of non - compliant products on the union market , ensuring effective and efficient enforcement of union harmonisation legislation within the union , improving cooperation between competent authorities and strengthening the controls on products entering the union market , whilst taking into account the impact on business and in particular on small and medium - sized enterprises . in addition , the evaluation should also assess the effectiveness of the market surveillance activities that receive union financing in the light of the requirements of union policies and legislation , as well as explore and propose new market - based solutions that could effectively complement the market surveillance actions that are currently being carried out , and shall include , but not be limited to , exploring the potential of compulsory independent third party auditing schemes .


### an effective way to ensure that unsafe or non - compliant products are not placed on the union market would be to detect such products before they are released for free circulation . customs authorities , as authorities in charge of the control on products entering the customs territory of the union , enjoy a complete overview of trade flows across the external borders , and should therefore be required to carry out adequate controls on a risk assessment basis , to contribute to a safer market place . a uniform enforcement of union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and customs authorities . these authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non - compliant products or information on economic operators where a higher risk of non - compliance has been identified . in turn , customs authorities should inform the market surveillance authorities in a timely manner of the release of products for free circulation , and the results of controls , where such information is relevant for the enforcement of union harmonisation legislation on products . furthermore , where the commission becomes aware of a serious risk posed by an imported product , it should inform the member states about those risks in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the union . ### an effective way to ensure that unsafe or non - compliant products are not placed on the union market would be to detect such products before they are released for free circulation . customs authorities , as authorities in charge of the control on products entering the customs territory of the union , enjoy a complete overview of trade flows across the external borders , and should therefore be required to carry out adequate controls on a risk assessment basis , to contribute to a safer market place , which ensures a high level of human health , consumer and environmental protection . a uniform enforcement of union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and customs authorities . these authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non - compliant products or information on economic operators where a higher risk of non - compliance has been identified . in turn , customs authorities should inform the market surveillance authorities in a timely manner of the release of products for free circulation , and the results of controls , where such information is relevant for the enforcement of union harmonisation legislation on products . furthermore , where the commission becomes aware of a serious risk posed by an imported product , it should inform the member states about those risks in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the union .


### market surveillance authorities may enter into memoranda of understanding with businesses or organisations representing businesses or end - users for the carrying out , or financing , of joint activities aimed at identifying non - compliance or promoting compliance in specific geographical areas or with respect to specific categories of product . ### market surveillance authorities may enter into memoranda of understanding with economic operators , or organisations representing economic operators or end - users for the carrying out , or financing , of joint activities aimed at raising awareness , providing advice and guidance in relation to the union harmonisation legislation , promoting voluntary actions , identifying non - compliance or promoting compliance in specific geographical areas or with respect to specific categories of product , including the products sold online .


### carry out product - testing in relation to market surveillance activities and investigations ; ### carry out testing of specific products or a specific category or group of products or specific risks related to a category or group of products in relation to market surveillance activities and investigations at the request of the commission , the network established under article 31 or market surveillance authorities ;


### the development of e - commerce is also due to a great extent to the proliferation of information society service providers , normally through platforms and for remuneration , which offer intermediary services by storing third party content , but without exercising any control over such content , thus not acting on behalf of an economic operator . removal of content regarding non - compliant products or where it is not feasible blocking access to non - compliant products offered through their services should be without prejudice to the rules laid down in directive 2000 / 31 / ec of the european parliament and of the council55 . in particular , no general obligation should be imposed on service providers to monitor the information which they transmit or store , nor should a general obligation be imposed upon them to actively seek facts or circumstances indicating illegal activity . furthermore , hosting service providers should not be held liable as long as they do not have actual knowledge of illegal activity or information and are not aware of the facts or circumstances from which the illegal activity or information is apparent . __________________ 55 directive 2000 / 31 / ec of the european parliament and of the council on certain legal aspects of information society services , in particular electronic commerce , in the internal market . ### the development of e - commerce is also due to a great extent to the proliferation of information society service providers , normally through platforms and for remuneration , which offer intermediary services by storing third party content , but without exercising any control over such content , thus not acting on behalf of an economic operator . removal of content regarding non - compliant products or where it is not feasible blocking access to non - compliant products offered through their services should be without prejudice to the rules laid down in directive 2000 / 31 / ec of the european parliament and of the council55 , while also taking into account commission recommendation 2018 / 334 of 1 march 2018 on measures to effectively tackle illegal content online . __________________ 55 directive 2000 / 31 / ec of the european parliament and of the council on certain legal aspects of information society services , in particular electronic commerce , in the internal market .


### to organise cooperation and the effective exchange of information and best practices between market surveillance authorities ; ### to organise cooperation and the effective exchange of information and best practices between market surveillance authorities as well as with customs authorities ;


### the power to take temporary measures , where there are no other effective means available to prevent a serious risk , including in particular temporary measures requiring hosting service providers to remove , disable or restrict access to content or to suspend or restrict access to a website , service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time ; ### the power to adopt measures , where there are no other effective means available to prevent a serious risk , including in particular measures requiring hosting service providers to remove , disable or restrict access to content or to suspend or restrict access to a website , service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time ;


### ‘ market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements under union harmonisation legislation and do not endanger health , safety or any other aspect of public interest protection ; ### ‘ market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements under union harmonisation legislation and do not endanger health and safety in general , health and safety in the workplace , the protection of consumers , public safety or any other aspect of public interest protection ;


### each member state shall designate one or more market surveillance authorities in its territory . it shall inform the commission , through the network established under article 31 , and the other member states of the market surveillance authorities designated by it and the areas of competence of each of those authorities , using the information and communication system referred to in article 34 . ### each member state shall designate one or more market surveillance authorities in its territory . it shall inform the commission and the other member states of its market surveillance authorities and the areas of competence of each of those authorities , using the information and communication system referred to in article 34 .


### market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale , by means of documentary checks and , where appropriate , physical and laboratory controls on the basis of a representative sample . ### market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency , by means of documentary checks and , where appropriate , sufficient physical and laboratory controls on the basis of sufficient representative samples .


### at the request of an applicant authority , the requested authority shall supply any information that the requested authority deems relevant to establish whether a product is non - compliant and to ensure that the non - compliance can be brought to an end . ### at the request of an applicant authority , the requested authority shall supply to the applicant authority without delay , and in any event within 30 days , any information that the requested authority deems relevant to establish whether a product is non - compliant and to ensure that the non - compliance can be brought to an end .


### the commission may exchange confidential market surveillance related information with regulatory authorities of third countries or international organisations where it has concluded confidentiality arrangements based on reciprocity with those authorities or organisations . ### in order to improve the efficiency of market surveillance in the union , the commission may exchange confidential market surveillance related information with regulatory authorities of third countries or international organisations where it has concluded confidentiality arrangements based on reciprocity with those authorities or organisations .


### the network shall be composed of a union product compliance board , administrative coordination groups and a secretariat . ### the network shall be composed of one representative from each of the single liaison offices referred to in article 11 , two representatives from the commission , and their respective alternates , administrative coordination groups and a secretariat .


### in order to support customs and market surveillance authorities in carrying out tasks related to controls on products entering the customs territory of the union , a more favourable treatment should be granted for products declared for free circulation by an authorised economic operator , as defined in article 38 of regulation no 952 / 2013 , pending the establishment of the procedure for the exchange of information on the status of the authorised economic operators and their record of compliance related to product safety . such an approach should allow a more targeted control , on a risk basis , of products released for free circulation . ### in order to support customs and market surveillance authorities in carrying out tasks related to controls on products entering the customs territory of the union , a more favourable treatment should be granted for products declared for free circulation by an authorised economic operator , as defined in article 38 of regulation no 952 / 2013 , pending the establishment of the procedure for the exchange of information on the status of the authorised economic operators and their record of compliance with the union harmonisation law , related to including but not limited to product safety . such an approach should allow a more targeted control , on a risk basis , of products released for free circulation .


### by [ 31 december 2024 ] and every five years thereafter , the commission shall shall carry out an evaluation of this regulation against the objectives it pursues and present a report on the main findings to the european parliament , to the council and to the european economic and social committee . . ### by [ 31 december 2024 ] and every three years thereafter , the commission shall carry out an evaluation of this regulation against the objectives it pursues and present a report on the main findings to the european parliament , to the council and to the european economic and social committee .


### the single liaison office of a member state shall be responsible for coordinating the enforcement and market surveillance activities of the market surveillance authorities designated by that member state . ### the single liaison office of a member state shall be responsible for coordinating the enforcement and market surveillance activities of the market surveillance authorities and other authorities responsible for the control of products entering the union market designated by that member state .


### member states shall ensure that their market surveillance authorities and single liaison office have the necessary resources , including sufficient budgetary and other resources , expertise , procedures and other arrangements for the proper performance of their duties . ### member states shall ensure that their market surveillance authorities and single liaison office have the necessary resources , including sufficient budgetary and other resources , expertise , procedures and other arrangements as well as a sufficient number of competent personnel at its disposal for the proper performance of their duties .


### the nature of the temporary measures taken by them against economic operators and of the corrective action taken by economic operators ; ### the details of the measures taken by them against economic operators , commitments given to them by economic operators and the details of the corrective action taken by economic operators ;


### the framework for market surveillance should be strengthened , with a view to further improving compliance with and enforcement of union harmonisation legislation on products . ### currently , the implementation of surveillance to guarantee compliance is insufficient . the framework for market surveillance should be strengthened in order to reach the set objectives , with a view to further improving compliance with and enforcement of union harmonisation legislation on products . surveillance of compliance should go beyond monitoring of safety of a product , and cover other eu standards such as labour , health and environmental standards .