### the minimum requirements shall be transparent , non - discriminatory , objective and relevant to the category and nature of port services concerned . ### the minimum requirements shall be transparent , non - discriminatory , objective and relevant to the category and nature of port services concerned and must not be used implicitly to introduce market barriers .


### the managing body of the port shall regularly consult stakeholders such as undertakings established in the port , providers of port services , operators of waterborne vessels , cargo owners , land transport operators and public administrations operating in the port area on the following : ### the managing body of the port shall regularly consult stakeholders such as undertakings established in the port , providers of port services , operators of waterborne vessels , cargo owners , workers representatives , land transport operators and public administrations operating in the port area on the following :


### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a non - tobacco dominant flavour other than tobacco or traditional flavours such as menthol , which may facilitate uptake of tobacco consumption or affect consumption patterns . .


### the labelling provisions also need to be adapted to new scientific evidence . for example the indication of the yields for tar , nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others . evidence also suggests that large combined health warnings are more effective than text - only warnings . in this light combined health warnings should become mandatory throughout the union and cover significant and visible parts of the packet surface . a minimum size should be set for all health warnings to ensure their visibility and effectiveness . ### the labelling provisions also need to be adapted to new scientific evidence . for example the indication of the yields for tar , nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others . it is essential to carry out an independent study beforehand , in order to establish whether large combined health warnings are more effective than text - only warnings in this light combined health warnings should become mandatory throughout the union and cover significant and visible parts of the packet surface . a minimum size should be set for all health warnings to ensure their visibility and effectiveness .


### cross - border distance sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this directive . common rules on a notification system are necessary to ensure that this directive achieves its full potential . the provision on notification of cross - border distance sales of tobacco in this directive should apply notwithstanding the notification procedure set out in directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services . business to consumer distance sale of tobacco products is further regulated by directive 97 / 7 / ec of the european parliament and the council of 20 may 1997 on the protection of consumers in respect of distance contracts , which will be replaced by directive 2011 / 83 / eu of the european parliament and the council of 25 october 2011 on consumer rights , as of 13 june 2014 . ### cross - border distance sales of tobacco products as well as free promotional or discounted distribution of tobacco products facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this directive . therefore , cross - border distance sales of tobacco and free and / or discounted distribution of tobacco should be prohibited .


### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive . ### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states and consistent with wto international obligations . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive .


### member states should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this directive , provided they are compatible with the treaty and do not jeopardise the full application of this directive . accordingly , member states could , for instance , maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the treaty , with wto obligations and do not affect the full application of this directive . a prior notification is required for technical regulations pursuant to directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on information society services44 . ### member states should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this directive , provided they are compatible with the treaty and with the wto provisions , and do not jeopardise the full application of this directive . a prior notification is required for technical regulations pursuant to directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on information society services44 .


### ‘ characterising flavour’ means a distinguishable aroma or taste other than tobacco , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy , menthol or vanilla observable before or upon intended use of the tobacco product ; ### ‘ non - tobacco dominant flavour’ means an overt distinguishable aroma or taste other than tobacco or menthol , resulting from an additive or combination of additives evident upon intended use of the tobacco product ;


### ‘ cigar’ means a roll of tobacco consumed via a combustion process and further defined in article 4 of council directive 2011 / 64 / eu of 21 june 2011 on the structure and rates of excise duty applied to manufactured tobacco46 ; ### ‘ cigar’ or ‘ cigarillo’ means a roll of tobacco consumed via a combustion process including a small type of cigar with a diameter of up to 8 mm and further defined in article 4 of council directive 2011 / 64 / eu of 21 june 2011 on the structure and rates of excise duty applied to manufactured tobacco46 ;


### ‘ flavouring’ means an additive that imparts aroma and / or taste ; ### ‘ flavouring’ means an additive that imparts aroma and / or taste except for menthol


### ‘ place on the market’ means to make products available to consumers located in the union , with or without payment , including by means of distance sale ; in case of cross - border distance sales the product is deemed to be placed on the market in the member state where the consumer is located ; ### ‘ place on the market’ means any supply of products for distribution , consumption or use in the union , with or without payment , including by means of distance sale ;


### ‘ substantial change of circumstances’ means an increase of the sales volumes by product category , such as pipe tobacco , cigar , cigarillo , by at least 10 % in at least 10 member states based on sales data transmitted in accordance with article 5 ; or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 member states for the respective product category based on ____ [ this date will be set at the moment of adoption of the directive ] eurobarometer report or equivalent prevalence studies ; ### ‘ substantial change of circumstances’ means an increase of the sales volumes by product category , such as pipe tobacco , cigar , cigarillo , by at least 20 % in the10 member states with the highest volume of sales , based on sales data transmitted in accordance with article 5 ; or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 member states for the respective product category based on ____ [ this date will be set at the moment of adoption of the directive ] eurobarometer report or equivalent prevalence studies ;


### member states shall prohibit the placing on the market of tobacco products with a characterising flavour . ### member states shall prohibit the placing on the market of tobacco products with a characterising flavour . menthol as a traditional tobacco product flavour is not considered to be characterising flavour and therefore , the use of menthol shall be allowed .


### member states shall prohibit the placing on the market of tobacco products with a characterising flavour . ### member states shall prohibit the placing on the market of tobacco products with additives that create or release a flavour which is not predominantly that of tobacco or menthol , in accordance with the provisions of paragraph 2 .


### be positioned at the top edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ; ### be positioned in the top half of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ;


### the general warning shall be printed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed on the other most visible surface of the unit packet and any outside packaging . ### the general warning shall be printed or affixed by means of non - removable stickers on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall appear on the other most visible surface of the unit packet and any outside packaging .


### printed in black helvetica bold type on a white background . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ; ### appear in black helvetica bold type on a white background . the warnings may be affixed by means of stickers , provided that such stickers are irremovable . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ;


### centred in the area in which they are required to be printed , parallel to the top edge of the unit packet and any outside packaging ; ### centred in the area in which they are required to appear , parallel to the top edge of the unit packet and any outside packaging ;


### member states shall ensure that all unit packets of tobacco products shall be marked with a unique identifier . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market . ### member states shall require that unique , secure and non - removable identification markings hereafter called unique identification markings , such as codes or stamps , are affixed to or form part of all unit packets and packages and any outside packaging of cigarettes . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market .


### the product name ; ### the product name and description ;


### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible . ### member states shall require that track and trace technology capable of reading and transmitting data electronically to the storage facility pursuant to paragraph 6 , the ownership for which is outside the control of tobacco manufacturers and their partners in the supply chain , is made available to all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies . such economic operators shall record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . in conformity with article 14 , this obligation shall be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible .


### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible . ### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets and outside packaging into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible .


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall conclude data storage contracts with a third party , which may be an agency of the member state , and which is legally independent from the tobacco companies or their partners in the supply chain , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . member states shall ensure full transparency . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall conclude data storage contracts with an independent third party which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who shall be appointed by the commission . the costs incurred as a result of the contract with the auditor and the database management services shall be covered by the tobacco manufacturers and importers . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### tobacco for oral use ### smokeless tobacco products


### member states may allow the following products , which are not in compliance with this directive , to be placed on the market until [ publications office , please insert the exact date : entry into force + 24 months ] : ### member states may allow the following products , which are not in compliance with this directive , to be placed on the market until [ publications office , please insert the exact date : entry into force + 42 months ] :


### maintaining two different set of rules , those for certificates issued pursuant to article 22 of the revised convention on the navigation on the rhine and for the union inland navigation certificate , does not ensure legal certainty and safety . ### given the different legal frameworks and timeframes for the decision - making procedures , it is difficult to maintain the equivalence between the union inland navigation certificates issued pursuant to directive 2006 / 87 / ec and the certificates issued pursuant to article 22 of the revised convention for rhine navigation . legal certainty is therefore not ensured , and this has a potentially negative impact on navigation safety .


### since the ccnr has built up significant expertise in updating technical requirements for inland navigation vessels , this expertise should be fully used for the inland waterways in the union . ### since the ccnr has built up significant expertise in developing and updating technical requirements for inland navigation vessels , this expertise should be fully used for the inland waterways in the union . the commission ' s services and the ccnr have signed an administrative arrangement in 2013 to reinforce their cooperation , particularly as regards the development of technical requirements concerning inland waterway vessels . within this framework , it has been agreed that a committee is to be established to draw up technical standards in the field of inland navigation to which reference can be made by the union and the ccnr in their respective regulations .


### changes in technical requirements need to be taken into account for reasons of safety of inland navigation and equivalence of certificates . in order to do so , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to adapt the annexes to this directive in line with scientific and technical progress or with developments in this area arising from the work of other international organisations , in particular the ccnr . it is particularly important that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure simultaneous , timely and appropriate submission of the relevant documents to the european parliament and to the council . ### in order to ensure a high level of safety and efficiency for inland navigation and to maintain the equivalence of the navigation certificates , the technical requirements defined in the annexes to this directive should be kept up to date in order to take into account scientific and technical progress , and technical standards in the field of inland navigation . in order to do so , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the adaptation of the annexes to this directive to scientific and technical progress or to developments and updates of technical standards arising from the work of other international organisations , in particular the ccnr . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### the commission shall publish and keep updated a list of the classification societies approved in accordance with the present article . ### the commission shall publish for the first time by . . , . + and keep updated , a list of the classification societies approved in accordance with the present article . _________________ + oj : please insert the date : one year after the date of entry into force of this directive .


### the delegation of power referred to in articles 3 , 4 , 8 , 10 , 22 and 23 is conferred on the commission for an indeterminate period of time from [ date of entry into force of the directive ] . ### the power to adopt delegated acts referred to in articles 3 , 4 , 8 , 10 , 22 and 23 shall be conferred on the commission for a period of five years from . . . * . 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 . _____________ * oj : please insert the exact date of entry into force of this directive .


### the european parliament or the council may revoke the delegation of power referred to in articles 3 , 4 , 8 , 10 , 22 and 23 at any time . a revocation decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified in the decision . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in articles 3 , 4 , 8 , 10 , 22 and 23 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### a delegated act adopted under articles 3 , 4 , 8 , 10 , 22 and 23 shall enter into force only if neither the european parliament nor the council objects within 2 months of the commission notifying them of the act . the european parliament or the council may extend this period by 2 months . ### a delegated act adopted pursuant to articles 3 , 4 , 8 , 10 , 22 and 23 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### the commission shall be empowered to adopt delegated acts in accordance with article 16 to define the specific rules and conditions for the applications of member states , including ceilings , for policy - based guarantees , ensuring in particular that their use does not lead to excessive levels of debt of public bodies . ### the commission shall be empowered to adopt delegated acts in accordance with article 16 to define the specific rules and conditions for the applications of member states , including ceilings , for policy - based guarantees , ensuring in particular that their use does not lead to excessive levels of debt of public bodies . those delegated acts shall comply with the principles laid down in regulation no [ . . . ] on the financial rules applicable to the annual budget of the union .


### these data are to be provided in the annual implementation reports as specified in article 44 and and article 101 of regulation no [ … ] . ### these data are to be provided in the annual implementation reports as specified in article 44 and and article 101 of regulation no [ … ] . the data are to be broken down by nuts level .


### in adopting measures in accordance to this regulation , the commission shall evaluate the environmental , trade , economic and social effects of those measures in the short and long terms and the administrative burden associated to their implementation . ### before adopting measures in accordance to this regulation , the commission shall evaluate the environmental , trade , economic and social effects of those measures in the short and long terms and the administrative burden associated to their implementation . in its evaluation , the commission shall take due account of the level of development , the vulnerability and the financial , material and technical capacities of the country concerned , as well as of the consequences said measures may have on development policies implemented in said country .


### the commission shall be empowered to adopt delegated acts , in accordance with article 9 , taking account of economic and technical trends , concerning the adaptation of the threshold for statistical coverage of inland waterways transport . ### the commission shall be empowered to adopt delegated acts , where necessary , in accordance with article 9 , taking account of economic and technical trends , concerning the adaptation of the threshold for statistical coverage of inland waterways transport . '


### the commission shall be empowered to adopt delegated acts in accordance with article 9 , taking account of economic and technical trends , concerning the adaptation of the definitions and the adoption of additional definitions . ### the commission shall be empowered to adopt delegated acts , where necessary , in accordance with article 9 , taking account of economic and technical trends , concerning the adaptation of the definitions and the adoption of additional definitions .


### the commission shall be empowered to adopt delegated acts in accordance with article 9 , taking account of economic and technical trends , concerning the adaptation of the data collection scope and the content of the annexes . ### the commission shall be empowered to adopt delegated acts , where necessary , in accordance with article 9 , taking account of economic and technical trends , concerning the adaptation of the data collection scope and the content of the annexes .


### ‘ economic operators’ means the manufacturer , the authorised representative , the importer and the distributor ; ### ‘ economic operators’ means a manufacturer , an authorised representative , an importer or the distributor ;


### ‘ harmonised standard’ means harmonised standard as defined in article 2 of regulation no [ … ] [ european standardisation ] ; ### ‘ harmonised standard’ means a standard as defined in article 2 of regulation no [ … ] [ european standardisation ] ;


### member states shall take all steps to ensure that only instruments that meet the requirements of this directive may be made available on the market . ### member states shall take all steps to ensure that only instruments that meet the applicable requirements of this directive may be made available on the market .


### member states shall take all steps to ensure that instruments continue to conform to the requirements of this directive . ### member states shall take all steps to ensure that instruments continue to conform to the applicable requirements of this directive .


### instruments used for the applications listed in points to of article 1 must satisfy the essential requirements set out in annex i and bear the ce marking and the inscriptions provided for in point 1 of annex iii . ### instruments used or intended to be used for the applications listed in points to of article 1 must satisfy the essential requirements set out in annex i and bear the ce marking and the inscriptions provided for in point 1 of annex iii .


### when placing on the market their instruments used for the applications listed in points to of article 1 , manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in annex i . ### when placing on the market their instruments intended to be used for the applications listed in points to of article 1 , manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in annex i .


### when placing on the market their instruments not used for the applications listed in points to of article 1 , manufacturers shall ensure that they bear the inscriptions provided for in point 2 of annex iii . ### when placing on the market their instruments not intended to be used for the applications listed in points to of article 1 , manufacturers shall ensure that they bear the inscriptions provided for in point 2 of annex iii .


### for the instruments used for the applications listed in points to of article 1 , manufacturers shall draw up the required technical documentation and carry out the relevant conformity assessment procedure referred to in article 14 or have it carried out . ### for the instruments intended to be used for the applications listed in points to of article 1 , manufacturers shall draw up the required technical documentation and carry out the relevant conformity assessment procedure referred to in article 14 or have it carried out .


### for the instruments not used for the applications listed in points to of article 1 , manufacturers shall affix the inscriptions provided for in point 2 of annex iii . ### for the instruments not intended to be used for the applications listed in points to of article 1 , manufacturers shall affix the inscriptions provided for in point 2 of annex iii .


### for the instruments used for the applications listed in points to of article 1 , manufacturers shall keep the technical documentation and the eu declaration of conformity for 10 years after the instrument has been placed on the market . ### for the instruments intended to be used for the applications listed in points to of article 1 , manufacturers shall keep the technical documentation and the eu declaration of conformity for 10 years after the instrument has been placed on the market .


### manufacturers shall ensure that the instrument is accompanied by instructions and information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . ### manufacturers shall ensure that the instrument is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . such instructions and safety information as well as any labelling shall be clear , understandable and intelligible .


### importers shall ensure that the instrument is accompanied by instructions and information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . ### importers shall ensure that the instrument is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned .


### manufacturers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the instrument or , where that is not possible , on its packaging or in a document accompanying the instrument . the address must indicate a single point at which the manufacturer can be contacted . ### manufacturers shall indicate their name , registered trade name or registered trade mark , their web address in a language easily understood by end - users and market surveillance authorities , and the address at which they can be contacted on the instrument or , where that is not possible , on its packaging or in a document accompanying the instrument . the address must indicate a single point at which the manufacturer can be contacted .


### before placing on the market an instrument used for the applications listed in points to of article 1 , importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer . they shall ensure that the manufacturer has drawn up the technical documentation , that the instrument bears the ce marking , the inscriptions provided for in point 1 of annex iii and is accompanied by the required documents , and that the manufacturer has complied with the requirements set out in article 6 and . ### before placing on the market an instrument intended to be used for the applications listed in points to of article 1 , importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer . they shall ensure that the manufacturer has drawn up the technical documentation , that the instrument bears the ce marking , the inscriptions provided for in point 1 of annex iii and is accompanied by the required documents , and that the manufacturer has complied with the requirements set out in article 6 and .


### where an importer considers or has reason to believe that an instrument used for the applications listed in points to of article 1 is not in conformity with the essential requirements set out in annex i , he shall not place the instrument on the market until it has been brought into conformity . furthermore , where the instrument presents a risk , the importer shall inform the manufacturer and the market surveillance authorities to that effect . ### where an importer considers or has reason to believe that an instrument intended to be used for the applications listed in points to of article 1 is not in conformity with the essential requirements set out in annex i , he shall not place the instrument on the market until it has been brought into conformity . furthermore , where the instrument presents a risk , the importer shall inform the manufacturer and the market surveillance authorities to that effect .


### before placing on the market an instrument not used for the applications listed in points to of article 1 importers shall ensure that the instrument bears the inscriptions provided for in point 2 of annex iii and that the manufacturer has complied with the requirements set out in article 6 and . ### before placing on the market an instrument not intended to be used for the applications listed in points to of article 1 importers shall ensure that the instrument bears the inscriptions provided for in point 2 of annex iii and that the manufacturer has complied with the requirements set out in article 6 and .


### importers shall ensure that , while an instrument used for the applications listed in points to of article 1 is under their responsibility , storage or transport conditions do not jeopardise its compliance with the essential requirements set out in annex i . ### importers shall ensure that , while an instrument intended to be used for the applications listed in points to of article 1 is under their responsibility , storage or transport conditions do not jeopardise its compliance with the essential requirements set out in annex i .


### distributors shall ensure that , while an instrument used for the applications listed in points to of article 1 is under their responsibility , storage or transport conditions do not jeopardise its compliance with the essential requirements set out in annex i . ### distributors shall ensure that , while an instrument intended to be used for the applications listed in points to of article 1 is under their responsibility , storage or transport conditions do not jeopardise its compliance with the essential requirements set out in annex i .


### for the instruments used for the applications listed in points to of article 1 , importers shall , for 10 years after the instrument has been placed on the market keep a copy of the eu declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities , upon request . ### for the instruments intended to be used for the applications listed in points to of article 1 , importers shall , for 10 years after the instrument has been placed on the market keep a copy of the eu declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities , upon request .


### before making an instrument used for the applications listed in points to of article 1 available on the market , distributors shall verify that the instrument bears the ce marking , the inscriptions provided for in point 1 of annex iii , that it is accompanied by the required documents and by instructions and information in a language which can be easily understood by consumers and other end - users in the member state in which the instrument is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 . ### before making an instrument intended to be used for the applications listed in points to of article 1 available on the market , distributors shall verify that the instrument bears the ce marking , the inscriptions provided for in point 1 of annex iii , that it is accompanied by the required documents and by instructions and information in a language which can be easily understood by consumers and other end - users in the member state in which the instrument is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 .


### before making an instrument used for the applications listed in points to of article 1 available on the market , distributors shall verify that the instrument bears the ce marking , the inscriptions provided for in point 1 of annex iii , that it is accompanied by the required documents and by instructions and information in a language which can be easily understood by consumers and other end - users in the member state in which the instrument is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 . ### before making an instrument used for the applications listed in points to of article 1 available on the market , distributors shall verify that the instrument bears the ce marking , the inscriptions provided for in point 1 of annex iii , that it is accompanied by the required documents and by instructions and information in a language which can be easily understood by consumers , including by vulnerable consumers , and other end - users in the member state in which the instrument is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 .


### before making an instrument not used for the applications listed in points to of article 1 available on the market , distributors shall verify that the instrument bears the inscriptions provided for in point 2 of annex iii and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 . ### before making an instrument not intended to be used for the applications listed in points to of article 1 available on the market , distributors shall verify that the instrument bears the inscriptions provided for in point 2 of annex iii and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 .


### economic operators shall , on request , identify the following to the market surveillance authorities : ### economic operators shall , on request , specify the following to the market surveillance authorities :


### economic operators shall be able to present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the instrument and for a period of 10 years after they have supplied the instrument . ### economic operators shall present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the instrument and for a period of 10 years after they have supplied the instrument . economic operators shall not be required to update that information after supply is finalised .


### the conformity of instruments to the essential requirements set out in annex i may be certified by either of the following procedures as selected by the applicant : ### the conformity of instruments to the essential requirements set out in annex i may be certified by either of the following procedures as selected by the manufacturer or his authorised representative :


### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the instrument is placed or made available . ### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the instrument is placed or made available . upon request of the market surveillance authority , the economic operator shall provide a copy of the eu declaration of conformity in paper form or by electronic means .


### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of the instrument . ### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of the instrument , with the requirements laid down in this directive .


### member states shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies , including compliance with article 24 . ### member states shall designate a single notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies , including compliance with article 24 .


### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that an instrument covered by this directive presents a risk to the aspects of public interest protection covered by this directive , they shall carry out an evaluation in relation to the instrument concerned covering all the requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities . ### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that an instrument covered by this directive presents a risk to the aspects of public interest protection covered by this directive , they shall carry out an evaluation in relation to the instrument concerned covering all the relevant requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities .


### member states shall ensure that appropriate restrictive measures are taken in respect of the instrument concerned without delay . ### member states shall ensure that appropriate restrictive measures are taken in respect of the instrument concerned , such as withdrawal of the instrument from their market , without delay .


### member states shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . ### member states shall build upon existing mechanisms to ensure correct application of the regime governing the ce marking and shall be obliged to take appropriate action in the event of improper use of the marking . member states shall lay down rules on penalties applicable to infringements by economic operators of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . such rules may include criminal penalties for serious infringements .


### the penalties provided for shall be effective , proportionate and dissuasive . ### the penalties referred to in the first paragraph shall be effective , proportionate to the seriousness of the offence , and dissuasive .


### member states shall notify those provisions to the commission by [ the date set out in the second subparagraph of article 42 ] at the latest and shall notify to it without delay any subsequent amendment affecting them . ### member states shall notify those provisions to the commission by [ the date set out in the second subparagraph of article 42 ] and shall notify to it without delay any subsequent amendment affecting them . the commission shall make those provisions publicly available by publishing them on the internet .


### 1 . design and construction of the instruments shall be such that the instruments will preserve their metrological qualities when properly used and installed and when used in an environment for which they are intended . the value of the mass must be indicated . ### 1 . design and construction of the instruments shall be such that the instruments will preserve their metrological qualities when properly used and installed and when used in an environment for which they are intended or in an environment which can be reasonably foreseen . the value of the mass must be indicated .


### 3 . the requirements of points 8 . 1 and 8 . 2 shall be met on a lasting basis during a period of time that is normal in view of the intended use of such instruments . ### 3 . the requirements of points 8 . 1 and 8 . 2 shall be met on a lasting basis during a period of time that is normal in view of the intended or reasonably foreseen use of such instruments .


### a notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the instruments with the approved type described in the eu - type examination certificate and with the appropriate requirements of this directive . ### an accredited in - house body or a notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the instruments with the approved type described in the eu - type examination certificate and with the appropriate requirements of this directive .


### a notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the conformity of the instruments with the applicable requirements of this directive . ### an accredited in - house body or a notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the conformity of the instruments with the applicable requirements of this directive .


### a notified body chosen by the manufacturer shall carry out appropriate examinations and tests , set out in the relevant harmonised standards and / or technical specifications , or equivalent tests , to check the conformity of the instrument with the applicable requirements of this directive , or have them carried out . in the absence of such a harmonised standard and / or technical specification the notified body concerned shall decide on the appropriate tests to be carried out . ### an accredited in - house body or a notified body chosen by the manufacturer shall carry out appropriate examinations and tests , set out in the relevant harmonised standards and / or technical specifications , or equivalent tests , to check the conformity of the instrument with the applicable requirements of this directive , or have them carried out . in the absence of such a harmonised standard and / or technical specification the notified body concerned shall decide on the appropriate tests to be carried out .


### directive 2003 / 98 / ec does not contain an obligation to allow re - use of documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , so that all generally accessible documents are re - usable . in other member states , the link between the two sets of rules is less clear and this is a source of legal uncertainty . ### directive 2003 / 98 / ec does not justify an obligation for member states to allow access to , and re - use of , public - sector documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . the directive only harmonises the conditions subject to which documents are made available for re - use . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , whereas other member states have legally separated the right of re - use from national rules on access to information and freedom of information .


### directive 2003 / 98 / ec should therefore lay down a clear obligation for member states to make all generally available documents re - usable . as it constitutes a limitation to the intellectual property rights hold by the authors of the documents , the scope of such a link between the right of access and the right of use should be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights . ### directive 2003 / 98 / ec limits the intellectual property rights held by the authors of the documents . the scope of such a link between the right of access and the right of use should therefore be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights .


### to facilitate re - use , public sector bodies should make documents available through machine readable formats and together with their metadata where possible and appropriate , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community ### to facilitate re - use , public sector bodies should make documents available through technology - neutral machine - readable formats and together with their metadata where possible and appropriate , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred in the process of meeting a given request for re - use . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should always lie with the public sector body charging for the re - use of documents . those charges should be set according to objective , transparent and verifiable criteria .


### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences . ### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible , preferably limiting them to the indication of source . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences .


### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences . ### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , should play an important role in this respect . therefore , member states should encourage the use of open licences that in time should become standardised across the union .


### it is necessary to ensure that the member states report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available , and the work of the independent authority . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### it is necessary to ensure that the member states report to the commission on the availability of public sector information for re - use , the conditions under which it is made available , and the work of the independent authority . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### the commission should assist the member states in implementing the directive in a consistent way by giving guidance , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties . ### the commission should assist the member states in implementing the directive in a consistent way by making proposals and laying down guidelines , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties .


### the means of redress shall include the possibility of review by an independent authority that is vested with specific regulatory powers regarding the re - use of public sector information and whose decisions are binding upon the public sector body concerned . ### the means of redress shall include a reference to the possibility of review by an authority in the member states .


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### paragraph 1 is replaced by the following : ‘ 1 . public sector bodies shall make their documents available in the pre - existing formats or languages and , where possible and appropriate , in technology - neutral , machine - readable format and together with their metadata . this shall not imply an obligation for public sector bodies to create , digitise or adapt documents or render them machine - readable in a technology - neutral manner in order to comply with the request , nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort , going beyond a simple operation . ’


### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination . ' ### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction , provision and dissemination .


### in exceptional cases , in particular where public sector bodies generate a substantial part of their operating costs relating to the performance of their public service tasks from the exploitation of their intellectual property rights , public sector bodies may be allowed to charge for the re - use of documents over and above the marginal costs , according to objective , transparent and verifiable criteria , provided this is in the public interest and subject to the approval of the independent authority referred to in article 4 , and without prejudice to paragraphs 3 and 4 of this article . ’ ### paragraph 1 shall not apply to : exceptional cases in which public sector bodies need to make a profit in order to cover a large part of the costs they have incurred in carrying out their public remit ; libraries , museums and archives .


### in article 7 , the words ‘ over and above the marginal costs or’ are inserted after ‘ calculation of charges’ . ### in article 7 , the third sentence is replaced by the following : ‘ the public sector body in question shall also indicate which factors will be taken into account in the calculation of charges as referred to in article 6 . ’


### in article 7 , the words ‘ over and above the marginal costs or’ are inserted after ‘ calculation of charges’ . ### in article 7 , the words ' when possible and appropriate ' are deleted and the words ‘ over and above the marginal costs or’ are inserted after ‘ calculation of charges’ .


### public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ### public sector bodies may allow re - use of documents without conditions or may impose conditions , where appropriate through a licence dealing with relevant issues . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition .


### public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ### public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall be made available through electronic means and shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall make practical arrangements to facilitate searches for documents available for re - use throughout the union , such as asset lists of main documents with relevant metadata , accessible preferably in technology - neutral , machine - readable format , and portal sites that are linked to asset lists .


### in article 11 , the following sentence is added at the end of paragraph 3 : ### paragraph 3 of article 11 shall read as follows : ‘ 3 . existing exclusive arrangements that do not qualify for an exception under paragraph 2 shall be terminated at the end of the contract or in any case not later than 31 december 2008 . such arrangements concerning libraries , museums and archives which do not qualify for an exception under paragraph 2 or paragraph 2a shall be terminated at the end of the contract or in any case not later than 31 december 20xx [ 6 years after entry into force of the directive ] . ’


### in article 13 the date of 1 july 2008 is replaced by [ 3 years after the transposition date ] and the following paragraph is added : ### in article 13 the date of 1 july 2008 is replaced by [ 5 years after the date of entry into force ] and the following paragraph is added :


### member states shall submit a yearly report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available and the work of the independent authority referred to in article 4 . ### member states shall submit a report to the commission every three years on the availability of public sector information for re - use , the conditions under which it is made available and the work of the independent authority referred to in article 4 .


### over the last decade , environmental issues , such as resource efficiency , biodiversity , climate change , and disaster risks , have become more important in policy making and should therefore also constitute critical elements in assessment and decision - making processes , especially for infrastructure projects . ### over the last decade , environmental issues , such as resource efficiency , biodiversity , climate change , and disaster risks , have become more important in policy making and should therefore also constitute important elements in assessment and decision - making processes , especially for infrastructure projects .


### over the last decade , environmental issues , such as resource efficiency , biodiversity , climate change , and disaster risks , have become more important in policy making and should therefore also constitute critical elements in assessment and decision - making processes , especially for infrastructure projects . ### over the last decade , environmental issues , such as resource efficiency , biodiversity , climate change , and disaster risks , have become more important in policy making and should therefore also constitute critical elements in assessment and decision - making processes , especially for infrastructure projects . as the commission has not determined guidelines for the application of the directive on conservation of historical and cultural heritage , the commission shall propose a list of criteria and indications with a view to a better implementation of the directive .


### experience has shown that in cases of civil emergency compliance with the provisions of directive 2011 / 92 / eu may have adverse effects , and provision should therefore be made to authorise member states not to apply that directive in appropriate cases . ### experience has shown that in cases of civil emergency compliance with the provisions of directive 2011 / 92 / eu may have adverse effects , and provision should therefore be made to authorise member states not to apply that directive in appropriate cases . in this respect , the directive shall take into account the provisions of the espoo convention , which , in cases of cross - border projects , oblige the participating states to notify and consult each other . in such cross - border projects , the commission shall , where and when appropriate and possible , play a more pro - active and facilitating role .


### the competent authorities should be required to determine the scope and level of detail of the environmental information to be submitted in the form of an environmental report . in order to improve the quality of the assessment and streamline the decision - making process , it is important to specify at union level the categories of information on which the competent authorities should make that determination . ### the competent authorities should be required to determine the scope and level of detail of the environmental information to be submitted in the form of an environmental report . in order to improve the quality of the assessment , the simplification of the procedures and streamline the decision - making process , it is important to specify at union level the categories of information on which the competent authorities should make that determination .


### since the objective of this directive , namely to ensure a high level of protection of the environment and of human health , through the establishment of minimum requirements for the environmental assessment of projects , cannot be sufficiently achieved by the member states and can therefore , by reason of the scope , seriousness and transboundary nature of the environmental issues to be addressed , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective . ### since the objective of this directive , namely to ensure a high level of protection of the environment and of human health , through the establishment of minimum requirements for the environmental assessment of projects , cannot be sufficiently achieved by the member states and can therefore , by reason of the scope , seriousness and transboundary nature of the environmental issues to be addressed , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the european union .


### the execution of construction or demolition works , or of other installations or schemes , ### - the execution of construction or of other installations or schemes , - the demolition works of construction or of installations or schemes , - other interventions in the natural surroundings and landscape including those involving the extraction of mineral resources .


### in paragraph 2 , the following definition is added : ### in paragraph 2 , the following definitions are added :


### projects for which the obligation to carry out assessments of the effects on the environment arises simultaneously from this directive and other union legislation shall be subject to coordinated or joint procedures fulfilling the requirements of the relevant union legislation . ### projects , including those with transboundary effect , for which the obligation to carry out assessments of the effects on the environment arises simultaneously from this directive and other union legislation may be subject to coordinated or joint procedures fulfilling the requirements of the relevant union legislation .


### material assets , cultural heritage and the landscape ; ### material assets , cultural heritage and the landscape in accordance with article 3 tue ;


### for projects listed in annex ii , the developer shall provide information on the characteristics of the project , its potential impact on the environment and the measures envisaged in order to avoid and reduce significant effects . the detailed list of information to be provided is specified in annex ii . a . ### for projects listed in annex ii , with the exception of projects which do not meet a relevant threshold or criterion set by the member state under paragraph 2 , the developer shall provide information on the characteristics of the project , its potential significant impact on the environment and the measures envisaged in order to avoid and reduce significant effects .


### when a case - by - case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2 , the competent authority shall take account of selection criteria related to the characteristics and location of the project and its potential impact on the environment . the detailed list of selection criteria to be used is specified in annex iii . “ ### for projects listed in annex ii , the competent authority shall take account of selection criteria related to the characteristics and location of the project and its potential impact on the environment . the detailed list of selection criteria to be used is specified in annex iii .


### the competent authority shall make its decision pursuant to paragraph 2 within three months from the request for development consent and provided that the developer has submitted all the requisite information . depending on the nature , complexity , location and size of the proposed project , the competent authority may extend that deadline by a further 3 months ; in that case , the competent authority shall inform the developer of the reasons justifying the extension and of the date when its determination is expected . ### the competent authority shall make its decision pursuant to paragraph 2 within three months from the request for development consent and provided that the developer has submitted all the requisite information . depending on the nature , complexity , location and size of the proposed project , the competent authority may extend that deadline by up to 3 months ; in that case , the competent authority shall inform the developer of the reasons justifying the extension and of the date when its determination is expected .


### depending on the nature , complexity , location and size of the proposed project , the competent authority may extend that deadline by a further 3 months ; in that case , the competent authority shall inform the developer of the reasons justifying the extension and of the date when its decision is expected . ### depending on the nature , complexity , location and size of the proposed project , the competent authority may extend that deadline by up to 3 months ; in that case , the competent authority shall inform the developer of the reasons justifying the extension and of the date when its determination is expected .


### ' 1 . where an environmental impact assessment must be carried out in accordance with articles 5 to 10 , the developer shall prepare an environmental report . the environmental report shall be based on the determination pursuant to paragraph 2 of this article and include the information that may reasonably be required for making informed decisions on the environmental impacts of the proposed project , taking into account current knowledge and methods of assessment , the characteristics , technical capacity and location of the project , the characteristics of the potential impact , alternatives to the proposed project and the extent to which certain matters are more appropriately assessed at different levels including the planning level , or on the basis of other assessment requirements . the detailed list of information to be provided in the environmental report is specified in annex iv . ### ' 1 . where an environmental impact assessment must be carried out in accordance with articles 5 to 10 , the developer shall prepare an environmental report . the environmental report shall be based on the determination pursuant to paragraph 2 of this article and include the information that may reasonably be required for making informed decisions on the environmental impacts of the proposed project , taking into account current knowledge and methods of assessment , the characteristics , technical capacity and location of the project and the characteristics of the potential impact .


### ' 1 . where an environmental impact assessment must be carried out in accordance with articles 5 to 10 , the developer shall prepare an environmental report . the environmental report shall be based on the determination pursuant to paragraph 2 of this article and include the information that may reasonably be required for making informed decisions on the environmental impacts of the proposed project , taking into account current knowledge and methods of assessment , the characteristics , technical capacity and location of the project , the characteristics of the potential impact , alternatives to the proposed project and the extent to which certain matters are more appropriately assessed at different levels including the planning level , or on the basis of other assessment requirements . the detailed list of information to be provided in the environmental report is specified in annex iv . ### ' 1 . where an environmental impact assessment must be carried out in accordance with articles 5 to 10 , the developer shall prepare an environmental report . the environmental report shall be based on the determination pursuant to paragraph 2 of this article and include the information that may reasonably be required for making informed decisions on the environmental impacts of the proposed project including a visual impact assessment when relevant , taking into account current knowledge and methods of assessment , the characteristics , technical capacity and location of the project , the characteristics of the potential impact , alternatives to the proposed project and the extent to which certain matters are more appropriately assessed at different levels including the planning level , or on the basis of other assessment requirements . the detailed list of information to be provided in the environmental report is specified in annex iv .


### the competent authority , after having consulted the authorities referred to in article 6 and the developer , shall determine the scope and level of detail of the information to be included by the developer in the environmental report , in accordance with paragraph 1 of this article . in particular , it shall determine : ### the competent authority , after having consulted the authorities referred to in article 6 and the developer , shall determine the scope and level of detail of the information as provided in annex iv to be included by the developer in the environmental report , in accordance with paragraph 1 of this article . in particular , it shall determine :


### the competent authority , after having consulted the authorities referred to in article 6 and the developer , shall determine the scope and level of detail of the information to be included by the developer in the environmental report , in accordance with paragraph 1 of this article . in particular , it shall determine : ### the competent authority , after having consulted the authorities referred to in article 6 and the developer , shall determine the scope and level of detail of the information to be included by the developer in the environmental report , in accordance with paragraph 1 of this article , if the operator so requests . in particular , it shall determine :


### the developer shall ensure that the environmental report is prepared by accredited and technically competent experts or ### the developer may also seek that the environmental report is prepared by independent experts .


### where accredited and technically competent experts assisted the competent authority to prepare the determination referred to in article 5 , the same experts shall not be used by the developer for the preparation of the environmental report . ### where independent experts assisted the competent authority to prepare the determination referred to in article 5 , the same experts shall not be used by the developer for the preparation of the environmental report .


### the detailed arrangements for the use and selection of accredited and technically competent experts , shall be determined by the member states . ### the detailed arrangements for the use and selection of independent experts , shall be determined by the member states in accordance with the provisions of paragraph 4 .


### the following paragraph 7 is added : ### the following paragraphs 7 and 8 are added :


### the time - frames for consulting the public concerned on the environmental report referred to in article 5 shall not be shorter than 30 days or longer than 60 days . in exceptional cases , where the nature , complexity , location or size of the proposed project so require , the competent authority may extend this time - frame by a further 30 days ; in that case , the competent authority shall inform the developer of the reasons justifying the extension . ### the time - frames for consulting the public concerned on the environmental report referred to in article 5 shall not be shorter than 30 days . in exceptional cases , where the nature , complexity , location or size of the proposed project so require , the competent authority may extend this consultation time - frame up to 60 days ; in that case , the competent authority shall inform the developer of the reasons justifying the extension .


### if the competent authority decides to grant development consent , it shall ensure that the development consent includes measures to monitor the significant adverse environmental effects , in order to assess the implementation and the expected effectiveness of mitigation and compensation measures , and to identify any unforeseeable adverse effects . ### if the competent authority decides to grant development consent , it shall ensure that the development consent includes , where appropriate , measures to monitor the significant adverse environmental effects of both construction and operational phases , in order to assess the implementation and the expected effectiveness of mitigation and compensation measures , and to identify any unforeseeable adverse effects and / or net biodiversity loss and to facilitate corrective action .


### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , during the construction and operational phases ; ### a description of the physical characteristics of the whole project , including , where relevant , its subsurface and underground , during the construction and operational phases , including demolition .


### the natural and man - made disaster risks and risk of accidents , with particular regard to hydromorphological changes , substances , or technologies or living organisms used , to specific surface and subsurface conditions or alternative use , and to the probability of accidents or disasters and the vulnerability of the project to these risks ; ### the natural and man - made disaster risks and risk of accidents , with particular regard to hydromorphological changes , substances , or technologies or living organisms used , to specific surface and subsurface conditions or reasonable alternative use , and to the probability of accidents or disasters and the vulnerability of the project to these risks ;


### impacts of the project on the environment , in particular on land , soil , water , air and biodiversity ; ### impacts of the project on the environment , in particular on land , soil , water , underground when relevant , air and biodiversity ;


### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , and the water use and land - use requirements during the construction and operational phases ; ### a description of the physical characteristics of the whole project , including , where relevant , its subsurface , and the water use and land - use requirements during the construction and operational phases and demolition if relevant .


### pursuant to article 206 of the treaty on the functioning of the european union the union , by establishing a customs union , is to contribute , in the common interest , to the harmonious development of world trade , the progressive abolition of restrictions on international trade and on foreign direct investment , and the lowering of customs and other barriers . ### pursuant to article 206 of the treaty on the functioning of the european union the union , by establishing a customs union , is to contribute , in the common interest , to the harmonious development of world trade , the progressive abolition of restrictions on international trade and on foreign direct investment , and the lowering of customs and other barriers . in fulfilling these tasks and in compliance with article 32 tfeu , the union draws its inspiration from the need to promote trade between member states and third countries .


### within the context of the world trade organisation and through its bilateral relations the union advocates an ambitious opening of international public procurement markets of the union and its trading partners , in a spirit of reciprocity and mutual benefit . ### amendmento within the world trade organisation and within the framework of its bilateral relations , the union supports an ambitious international opening of the public procurement markets of the union and of its trade partners , in a spirit of reciprocity , transparency , equal treatment and mutual benefit .


### many third countries are reluctant to open their public procurement markets to international competition , or to open those markets further than what they have already done . as a result , union economic operators face restrictive procurement practices in many of the trading partner of the union . those restrictive procurement practices result in the loss of substantial trading opportunities . ### many third countries are reluctant to open their public procurement markets to international competition , or to open those markets further than what they have already done . this reluctance has been exacerbated by the economic crisis under way , which has prompted a number of third countries to adopt protectionist policies and protect their own markets to the detriment of foreign economic operators .


### directives 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors and 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts contain only a few provisions concerning the external dimension of the public procurement policy of the union , in particular articles 58 and 59 of directive 2004 / 17 / ec . these provisions however only have a limited scope and due to a lack of guidance they are not much applied by contracting entities . ### directives 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors and 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts contain only a few provisions concerning the external dimension of the public procurement policy of the union , in particular articles 58 and 59 of directive 2004 / 17 / ec . however , these provisions are limited to procurement by utilities and are too narrow in their scope to make a substantial impact on negotiations on market access .


### in accordance with article 207 tfeu the common commercial policy in the field of public procurement is to be based on uniform principles . ### in accordance with article 207 tfeu the common commercial policy in the field of public procurement is to be based on uniform principles . in this regard , the union needs to increase its negotiating power to improve , on the basis of its primary and secondary legislation , access to the public markets of third countries .


### the commission should assess whether to approve that contracting authorities / entities within the meaning of directives [ 2004 / 17 / ec , 2004 / 18 / ec and directive [ … . ] of the european parliament and the council of [ … . ] … . on the award of concession contracts ] exclude , for contracts with an estimated value equal or above eur 5 . 000 . 000 from procedures for the award of contracts goods and services not covered by the international commitments undertaken by the european union . ### contracting authorities / entities within the meaning of directives [ 2004 / 17 / ec , 2004 / 18 / ec and directive [ … . ] of the european parliament and the council of [ … . ] … . on the award of concession contracts ] should be able to exclude from procedures for the award of contracts tenders comprising goods and / or services originating from third countries , in which the value of the non - covered goods or services exceeds 50 % of the total value of these goods or services .


### in order to enable the commission to decide on any exclusion of third - country goods and services not covered by the international commitments of the union , contracting authorities / entities should notify the commission of their intention to exclude such goods and services , using a standard form that contains sufficient information to enable the commission to decide . ### in order to enable the commission to assess whether to exclude third - country goods and services not covered by the international commitments of the union , contracting authorities / entities should notify the commission of their intention to exclude such goods and services , using a standard form that contains sufficient information to enable the commission to decide .


### for contracts with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures result in serious and recurring discriminations of eu economic operators , goods and services . ### for contracts with an estimated value equal or above eur 5 . 000 . 000 the commission should authorise the intended exclusion if the international agreement concerning market access in the field of public procurement between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures result in serious and recurring discriminations of eu economic operators , goods and services .


### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external procurement investigation into restrictive procurement practices allegedly maintained by a third country . in particular it shall take into account the fact that the commission has approved a number of intended exclusions concerning a third country pursuant to article 6 of this regulation . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community’s rights under international trade rules , in particular those established under the auspices of the world trade organization . ### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external procurement investigation into restrictive procurement practices allegedly maintained by a third country . in particular it shall take into account the fact that the commission has approved a number of intended exclusions concerning a third country pursuant to this regulation . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community’s rights under international trade rules , in particular those established under the auspices of the world trade organization .