### the 2 140 customs offices17 that are present over the external borders of the european union need to be properly equipped to ensure the operation of the customs union . the need for adequate and equivalent customs controls is ever more pressing not only by reason of the traditional function of customs to collect revenue but also increasingly by the necessity to significantly reinforce the control of goods entering and exiting union ' s external borders in order to ensure both safety and security . however , at the same time , those controls on the movement of goods across the external borders should not impair but rather facilitate legitimate trade with third countries . _________________ 17 annex of the annual 2016 report of the customs union performance available on : https : / / ec . europa . eu / info / publications / annual - activity - report - 2016 - taxation - and - customs - union_en . ### the 2 140 customs offices17 that are present over the external borders of the european union need to be properly equipped to ensure smooth and effective&#160 ; operation of the customs union . the need for adequate and equivalent customs controls is ever more pressing not only by reason of the traditional function of customs to collect revenue but also increasingly by the necessity to significantly reinforce the control of goods entering and exiting union ' s external borders in order to ensure safety , security and protection of the eu financial interests . however , at the same time , those controls on the movement of goods across the external borders should not impair but rather facilitate legitimate trade with third countries . _________________ 17 annex of the annual 2016 report of the customs union performance available on : https : / / ec . europa . eu / info / publications / annual - activity - report - 2016 - taxation - and - customs - union_en .


### although central implementation is indispensable in order to achieve the specific objective of ensuring equivalent customs controls , given the technical nature of this instrument , preparatory work is required at technical level . therefore , implementation should be supported by assessments of needs that are dependent on national expertise and experience through the involvement of customs administrations of the member states . those assessments of needs should be based on a clear methodology including a minimum number of steps ensuring the collection of the required information . ### although central implementation is indispensable in order to achieve the specific objective of ensuring equivalent customs controls , given the technical nature of this instrument , preparatory work is required at technical level . therefore , implementation should be supported by individual assessments of needs that are dependent on national expertise and experience through the involvement of customs administrations of the member states . those assessments of needs should be based on a clear methodology including a minimum number of steps ensuring the collection of the required information .


### to ensure regular monitoring and reporting , a proper framework for monitoring the results achieved by the instrument and actions under it should be put in place . such monitoring and reporting should be based on indicators measuring the effects of the actions under the instrument . reporting requirements should include some information on customs control equipment beyond a certain cost threshold . ### to ensure regular monitoring and reporting , a proper framework for monitoring the results achieved by the instrument and actions under it should be put in place . such monitoring and reporting should be based on indicators measuring the effects of the actions under the instrument . member states should ensure transparent and clear procurement procedure . reporting requirements should include detailed information on customs control equipment and procurement procedure beyond a certain cost threshold , and justification of the expenses .


### the preparation of the work programmes referred to in paragraph 1 shall be supported by an assessment of needs , which shall consist of the following at a minimum : ### the preparation of the work programmes referred to in paragraph 1 shall be supported by an individual assessment of needs , which shall consist of the following at a minimum :


### the measures applicable to spirit drinks should contribute to attaining a high level of consumer protection , preventing deceptive practices and attaining market transparency and fair competition . they should safeguard the reputation which the union’s spirit drinks have achieved in the union and on the world market by continuing to take into account the traditional practices used in the production of spirit drinks as well as increased demand for consumer protection and information . technological innovation should also be taken into account in respect of spirit drinks , where such innovation serves to improve quality , without affecting the traditional character of the spirit drinks concerned . the production of spirit drinks is strongly linked to the agricultural sector . besides representing a major outlet for the agriculture of the union , this link is determinant for the quality and reputation of the spirit drinks produced in the union . this strong link to the agricultural sector should therefore be emphasised by the regulatory framework . ### the measures applicable to spirit drinks should contribute to attaining a high level of consumer protection , preventing deceptive practices and attaining market transparency and fair competition . they should safeguard the reputation which the union’s spirit drinks have achieved in the union and on the world market by continuing to take into account the traditional practices used in the production of spirit drinks as well as increased demand for consumer protection and information . technological innovation should also be taken into account in respect of spirit drinks , where such innovation serves to improve quality , without affecting the traditional character of the spirit drinks concerned . the production of spirit drinks is governed by regulations 178 / 2002 on the general principles of food law , 1169 / 2011 on the provision of food information to consumers and 2017 / 625 on official controls on food and feed , and is strongly linked to the agricultural sector . besides representing a major outlet for the agriculture of the union , this link is determinant for the quality , safety and reputation of the spirit drinks produced in the union . this strong link to the agri - food sector should therefore be emphasised by the regulatory framework .


### - the addition to ethyl alcohol of agricultural origin , distillates of agricultural origin or spirit drinks of any of the following : ### - the addition to ethyl alcohol of agricultural origin , distillates of agricultural origin or spirit drinks of one or more of the following :


### by adding to a spirit drink any of the following : ### by adding to a spirit drink one or more of the following :


### ‘ compound term’ means the combination of the terms of a sales denomination of a spirit drink provided for in part i of annex ii or the terms of a geographical indication , describing a spirit drink , from which all the alcohol of the final product originates , with any of the following : ### ‘ compound term’ means the combination of the terms of a sales denomination of a spirit drink provided for in part i of annex ii or the terms of a geographical indication , describing a spirit drink , from which all the alcohol of the final product originates , with one or more of the following :


### ‘ allusion’ means the direct or indirect reference to one or more spirit drinks listed in part i of annex ii or geographical indications , other than the reference in a compound term or list of ingredients referred to in article 8 ; ### ‘ allusion’ means the direct or indirect reference to a spirit drinks listed in part i of annex ii or geographical indications , other than the reference in a compound term or list of ingredients referred to in article 8 ;


### solely be sweetened in accordance with point of annex i and in order to round off the final taste of the product . ### solely be sweetened in accordance with point of annex i and in order to round off the final taste of the product , taking into account the tradition and specific legislation of each member state .


### where a spirit drink meets the requirements of more than one of the categories of spirit drinks 15 to 47 of part i of annex ii , it may be sold under one or more of the relevant sales denominations provided for under those categories . ### where a spirit drink meets the requirements of more than one of the categories of spirit drinks listed in part i of annex ii , it may be placed on the market under one or more of the prescribed names provided for under those categories .


### supplemented or replaced by a geographical indication referred to in chapter iii , or supplemented in accordance with national provisions by another geographical indication , provided that this does not mislead the consumer ; or ### supplemented or replaced by a geographical indication referred to in chapter iii , or supplemented in accordance with national provisions by the name of another geographical reference , provided that this does not mislead the consumer ; or


### if a sales denomination is supplemented or replaced in accordance with point of the first subparagraph , the geographical indication referred to in that point may only be supplemented either : ### if a legal name is supplemented or replaced in accordance with point of the first subparagraph , the geographical indication referred to in that point may only be supplemented either :


### by terms already in use on 20 february 2008 for existing geographical indications within the meaning of article 34 ; or ### by terms already in use on 20 february 2008 for existing geographical indications within the meaning of article 34 , including the terms traditionally used in member states to designate that a product has a protected designation of origin under national law quality signs ; or


### the alcohol used in the production of the foodstuffs originates exclusively from the spirit drinks referred to in the compound term or in the allusion , except for ethyl alcohol that may be present in flavourings used for the production of that foodstuff ; and ### the alcohol used in the production of the foodstuffs originates exclusively from the spirit drinks referred to in the compound term or in the allusion , except for ethyl alcohol that may be present in flavourings used for the production of that foodstuff and ethyl alcohol originating from an alcoholic drink other than a spirit ; and


### where the origin of a spirit drink is indicated , it shall correspond to the country or territory of origin in accordance with article 60 of regulation no 952 / 2013 of the european parliament and of the council16 . _________________ 16 regulation no 952 / 2013 of the european parliament and of the council of 9 october 2013 laying down the union customs code . ### where the origin of a spirit drink is indicated it shall correspond to the&#160 ; place or region where the stage in the production process of the finished product , which conferred on the spirit drink its character and essential qualities , took place .


### the union symbol for the protected geographical indication may be used for the labelling and presentation of spirit drinks . ### the union symbol for the registered geographical indication may be used for the labelling and presentation of spirit drinks .


### protected geographical indications and the spirit drinks using those protected names in conformity with the product specification shall be protected against : ### registered geographical indications shall be protected against :


### by comparable products not complying with the product specification of the protected name ; or ### by comparable products not complying with the product specification of the protected name , including when those products are used as an ingredient ; or


### the commission shall adopt implementing acts , without applying the procedure referred to in article 44 , establishing and maintaining a publicly accessible updated electronic register of geographical indications of spirit drinks recognised under this scheme . ### the commission shall adopt delegated acts , without applying the procedure referred to in article 44 , establishing and maintaining a publicly accessible updated electronic register of geographical indications of spirit drinks recognised under this scheme .


### the commission may adopt implementing acts laying down detailed rules on the form and content of the register . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 44 . ### the commission may adopt delegated acts laying down detailed rules on the form and content of the register . those delegated acts shall be adopted in accordance with the examination procedure referred to in article 44 .


### notwithstanding the national legislation of member states , the costs of such verification of compliance with the product specification shall be borne by the food business operators which are subject to those controls . ### notwithstanding the national legislation of member states , the costs of such verification of compliance with the product specification shall be borne by the operators which are subject to those controls .


### in order to ensure the rights or legitimate interests of producers or food business operators , the commission may , by means of delegated acts adopted in accordance with article 43 , set out : ### in order to ensure the rights or legitimate interests of producers or operators , the commission may , by means of delegated acts adopted in accordance with article 43 , set out :


### in order to ensure the efficiency of the checks provided for in this chapter , the commission shall be empowered to adopt delegated acts in accordance with article 43 concerning the necessary measures regarding the notification of food business operators to the competent authorities . ### in order to ensure the efficiency of the checks provided for in this chapter , the commission shall be empowered to adopt delegated acts in accordance with article 43 concerning the necessary measures regarding the notification of operators to the competent authorities .


### a spirit drink produced exclusively by alcoholic fermentation and distillation of sugar - cane juice which has the aromatic characteristics specific to rum and a volatile substances content equal to or exceeding 225 grams per hectolitre of 100 % vol . alcohol . this spirit drink may be placed on the market with the word ‘ agricultural’ qualifying the sales denomination ‘ rum’ accompanied by any registered geographical indications of the french overseas departments and the autonomous region of madeira . ### a spirit drink produced exclusively by alcoholic fermentation and distillation of sugar - cane juice which has the aromatic characteristics specific to rum and a volatile substances content equal to or exceeding 225 grams per hectolitre of 100 % vol . alcohol . this spirit drink may be placed on the market with the word ‘ agricultural’ qualifying the legal name ‘ rum’ only when it is accompanied by any registered geographical indications of the french overseas departments and the autonomous region of madeira .


### neither cider spirit nor perry spirit shall be flavoured . ### neither cider spirit nor perry spirit shall be flavoured . however , that shall not exclude traditional production methods .


### in order to ensure the traceability of deactivated firearms , they should be registered in national registries . ### in order to ensure the traceability of deactivated firearms , they should be registered in regularly updated national registries accessible by each member state’s law enforcement authorities .


### some semi - automatic firearms can be easily converted to automatic firearms , thus posing a threat to security . even in the absence of conversion to category ' a ' , certain semi - automatic firearms may be very dangerous when their capacity regarding the number of rounds is high . such semi - automatic weapons should therefore be banned for civilian use . ### some semi - automatic firearms can be easily converted to automatic firearms , thus posing a threat to security . even in the absence of conversion to category ' a ' , certain semi - automatic firearms may be very dangerous when their capacity regarding the number of rounds is exceptionally high . such semi - automatic weapons could therefore be considered restricted for civilian use .


### to avoid that markings are easily erased and to clarify on which components the marking should be affixed , common union rules on marking should be introduced . ### to avoid that markings are easily erased and to clarify on which components the marking should be affixed , common union rules on marking should be introduced . these rules should take account of the new materials used in weapon manufacture and the emergence of three - dimensional weapons . they should also take into account imported weapons .


### firearms may be used for far more than 20 years . in order to ensure their traceability , records of them should be kept for an indeterminate period of time until destruction is certified . ### firearms may be used for far more than 20 years . in order to ensure their traceability , records of them should be kept for an indeterminate period of time until destruction is certified by the relevant authorities .


### furthermore , the risk of alarm weapons and other types of blank firing weapons being converted to real firearms is high , and in some of the terrorist acts converted arms were used . it is therefore essential to address the problem of converted firearms being used in criminal offences , notably by including them in the scope of the directive . technical specifications for alarm and signal weapons as well as for salute and acoustic weapons should be adopted in order to ensure that they cannot be converted into firearms . ### technical specifications for alarm and signal weapons as well as for salute and acoustic weapons are adopted in order to ensure that they cannot be converted into firearms .


### furthermore , the risk of alarm weapons and other types of blank firing weapons being converted to real firearms is high , and in some of the terrorist acts converted arms were used . it is therefore essential to address the problem of converted firearms being used in criminal offences , notably by including them in the scope of the directive . technical specifications for alarm and signal weapons as well as for salute and acoustic weapons should be adopted in order to ensure that they cannot be converted into firearms . ### furthermore , the risk of alarm weapons and other types of blank firing weapons being converted to real firearms is high , and in some of the terrorist acts converted arms were used . it is therefore essential to address the problem of converted firearms being used in criminal offences , notably by including them in the scope of the directive . technical specifications for alarm and signal weapons as well as for salute and acoustic weapons should be adopted in order to ensure that it is impossible to convert them into firearms .


### in order to improve the functioning of the information exchange between member states , the commission should assess the necessary elements of a system to support such exchange of information contained in the computerised data - filing systems in place in member states . the commission’s assessment may be accompanied , if appropriate , by a legislative proposal taking into account existing instruments regarding exchange of information . ### in order to improve the functioning of the information exchange between member states , the commission should assess the necessary elements of a system to support such exchange of information contained in the computerised data - filing systems in place in member states . the commission’s assessment may be accompanied , if appropriate , by a legislative proposal taking into account existing instruments regarding exchange of information . in addition to meeting the need to keep track of weapons held by private individuals or other bodies , in accordance with the law , such a system should enable weapons to be traced when they have been seized by , or handed over to , the authorities or forfeited to member states , thus making it possible to ascertain what happens to weapons until such time as they are destroyed , further used , or again placed on the market .


### for the purposes of this directive , ' broker ' shall mean any natural or legal person , other than a dealer whose trade or business consists wholly or partly in buying , selling or arranging the transfer within a member state , from one member state to another member state or exporting to a third country fully assembled firearms , their parts and ammunition . ### for the purposes of this directive , ' broker ' shall mean any natural or legal person , other than a dealer whose trade or business consists wholly or partly in buying , selling or arranging the transfer within a member state , from one member state to another member state or exporting to a third country or importing to a member state from a third country fully assembled firearms , their parts and ammunition .


### ' 1 . this directive is without prejudice to the application of national provisions concerning the carrying of weapons , hunting or target shooting . ### paragraph 1 is replaced by the following : ' 1 . this directive is without prejudice to the application of national provisions concerning the carrying of weapons , hunting or target shooting , or to more stringent legislation on illegal arms sales . '


### for the purposes of identifying and tracing each assembled firearm , member states shall , at the time of manufacture of each firearm or at the time of import to the union , require a unique marking including the name of the manufacturer , the country or place of manufacture , the serial number and the year of manufacture , if not already part of the serial number . this shall be without prejudice to the affixing of the manufacturer ' s trademark . ### for the purposes of identifying and tracing each assembled firearm , member states shall , at the time of manufacture of each firearm or at the time of import to the union , require a unique marking including the name of the manufacturer , the country or place of manufacture , the serial number , the year of manufacture , if not already part of the serial number and the type or model of the firearm as well as its calibre . this shall be without prejudice to the affixing of the manufacturer ' s trademark .


### for the purposes of identifying and tracing each assembled firearm , member states shall , at the time of manufacture of each firearm or at the time of import to the union , require a unique marking including the name of the manufacturer , the country or place of manufacture , the serial number and the year of manufacture , if not already part of the serial number . this shall be without prejudice to the affixing of the manufacturer ' s trademark . ### for the purposes of identifying and tracing each assembled firearm , member states shall , at the time of manufacture of each firearm or at the time of import to the union or as soon as possible thereafter , require a unique marking including the name of the manufacturer , the country or place of manufacture , the serial number and the year of manufacture , if not already part of the serial number . this shall be without prejudice to the affixing of the manufacturer ' s trademark .


### member states shall make the pursuit of the activity of dealer or broker within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking . ### member states shall make the pursuit of the activity of dealer or broker within their territory conditional upon authorisation on the basis of at least a check of the personal and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking .


### member states shall make the pursuit of the activity of dealer or broker within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking . ### member states shall make the pursuit of the activity of dealer or broker within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking . this authorisation must be for a limited period and renewable only after thorough checking of the dealer ' s or broker ' s registers of sales and acquisitions .


### member states shall make the pursuit of the activity of dealer or broker within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking . ### member states shall make the pursuit of the activity of dealer or broker within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer or broker , and also on the basis of the transparency of the commercial activity . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking .


### this filing system shall record each firearm ' s type , make , model , calibre and serial number , as well as the names and addresses of the supplier and the person acquiring or possessing the firearm . the record of firearms , including deactivated firearms , shall be maintained until destruction of the firearm has been certified by the competent authorities . ### this filing system shall record each firearm ' s type , make , model , calibre and serial number , as well as the names and addresses of the person disposing of the firearm and the person acquiring or possessing it . the record of firearms , including deactivated firearms , shall be maintained until destruction of the firearm has been certified by the competent authorities .


### the system referred to in paragraph 1 shall include at least a check of the private and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking . ### the system referred to in paragraph 1 shall include at least a check of the private and professional integrity and of the abilities of the dealer or broker and also a check of the transparency of the commercial activity . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking .


### the system referred to in paragraph 1 shall include at least a check of the private and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking . ### the system referred to in paragraph 1 shall include at least a check of the personal and professional integrity and of the abilities of the dealer or broker . in the case of a legal person , the check shall be on the legal person and on the person who directs the undertaking .


### are at least 18 years of age , except in relation to the possession of firearms for hunting and target shooting , provided that in that case persons of less than 18 years of age have parental permission , or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence , or are within a licenced or otherwise approved training centre ; ### are at least 18 years of age , except in relation to the acquisition , other than through purchase , and possession of firearms for hunting and target shooting , provided that in that case persons of less than 18 years of age have parental permission , or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence , or are within a licenced or otherwise approved training centre ;


### member states shall take all appropriate steps to prohibit the acquisition and the possession of the firearms and ammunition classified in category a and to destroy those firearms and ammunition held in violation of this provision and seized . ### except where expressly provided otherwise , member states shall take all appropriate steps to prohibit the acquisition and the possession of the firearms and ammunition classified in category a and to ensure that such weapons are forfeited to the state or , where deemed appropriate , destroyed , if they are held unlawfully .


### the acquisition of firearms and their parts and ammunition concerning categories a , b and c by means of distance communication , as defined in article 2 of directive 97 / 7 / ec of the european parliament and of the council , shall be authorised only with respect to dealers and brokers and shall be subject to the strict control of the member states . ### member states shall authorise the acquisition and selling of firearms and their parts and ammunition concerning categories a , b c and d set out in annex i by means of distance communication , as defined in article 2 of directive 97 / 7 / ec of the european parliament and of the council , only through authorised dealers and brokers . member states shall subject such acquisitions and sales to a strict control , including secure verification of the validity of the license for acquisition of firearms and ammunition and the identity of their buyer .


### member states shall make arrangements for the deactivation of firearms to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable . member states shall , in the context of this verification , provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm . ### member states shall make arrangements for the deactivation of firearms to be verified by a competent authority in order to ensure that the modifications made to each of the essential components of a firearm render it irreversibly inoperable . member states shall , in the context of this verification , provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm .


### the commission shall submit every five years a report to the european parliament and the council on the application of this directive , accompanied , if appropriate , by proposals in particular as regards the categories of firearms of annex i and the issues related to new technologies such as 3d printing . the first report shall be submitted two years after the entry into force of this directive . ### the commission shall submit every five years a report to the european parliament and the council on the application of this directive , accompanied , if appropriate , by proposals in particular as regards the categories of firearms of annex i and the issues related to the modular design of arms and to new technologies such as 3d printing . the first report shall be submitted two years after the entry into force of this directive .


### the commission shall submit every five years a report to the european parliament and the council on the application of this directive , accompanied , if appropriate , by proposals in particular as regards the categories of firearms of annex i and the issues related to new technologies such as 3d printing . the first report shall be submitted two years after the entry into force of this directive . ' ### the commission shall submit every five years a report to the european parliament and the council on the application of this directive , including a fitness check of the new provisions , accompanied , if appropriate , by proposals in particular as regards the categories of firearms of annex i and the issues related to new technologies such as 3d printing . the first report shall be submitted two years after the entry into force of this directive .


### alarm and signal weapons , salute and acoustic weapons as well as replicas ; ### firearms under categories a , b and points 1 to 4 of category c , after having been converted to alarm , signal , salute , acoustic , gas , paintball or airsoft , flobert , or percussion lock weapons .


### the provisions of directive 2013 / 32 / eu related to the application of the safe country of origin concept should be applicable in relation to third countries that are on the eu common list established by this regulation . this means , in particular , that the circumstance that a third country is on the eu common list of safe countries of origin cannot establish an absolute guarantee of safety for nationals of that country and does not dispense therefore with the need to conduct an appropriate individual examination of the application for international protection . in addition , it should be recalled that , where an applicant shows that there are serious reasons to consider the country not to be safe in his or her particular circumstances , the designation of the country as safe can no longer be considered relevant for him or her . ### the provisions of directive 2013 / 32 / eu related to the application of the safe country of origin concept should be applicable in relation to third countries that are on the eu common list established by this regulation . this means , in particular , that the circumstance that a third country is on the eu common list of safe countries of origin cannot constitute an exclusive criterion nor establish a systematic and absolute guarantee of safety for nationals of that country , and should not mean therefore that the national authorities may dispense with their obligation to conduct an appropriate and thorough individual examination of the application for international protection . in addition , it should be recalled that , where , in the light of the applicant ' s individual situation , there are serious reasons to consider the country not to be safe in his or her particular circumstances , the designation of the country as safe can no longer be considered relevant for him or her . member states should be aware that for some minority groups such as lesbian , gay , bisexual , transgender and intersex persons , claiming to belong to this minority as part of the asylum process can in itself be enough to put these individuals at risk in their country of origin . therefore , there should be no burden of proof on applicants to demonstrate or give evidence that they belong to a vulnerable or minority group , especially where such burden of proof violates a person ' s dignity . the right of applicants to an effective remedy in the case of a negative decision should be guaranteed .


### the commission should regularly review the situation in third countries that are on the eu common list of safe countries of origin . in case of sudden change for the worse in the situation of a third country on the eu common list , 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 suspending the presence of this third country from the eu common list for a period of one year where it considers , on the basis of a substantiated assessment , that the conditions set by directive 2013 / 32 / eu for regarding a third country as safe country of origin are no longer met . for the purpose of this substantiated assessment , the commission should take into consideration a range of sources of information at its disposal including in particular , its annual progress reports for third countries designated as candidate countries by the european council , regular reports from the european external action service and the information from member states , the european asylum support office , the united nations high commissioner for refugees , the council of europe and other relevant international organisations . the commission should be able to extend the suspension of the presence of a third country from the eu common list for a period of maximum one year , where it has proposed an amendment to this regulation in order to remove this third country from the eu common list of safe countries of origin . 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 should regularly review the situation in third countries that are on the eu common list of safe countries of origin . in case of sudden change for the worse in the situation of a third country on the eu common list , 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 suspending the presence of this third country from the eu common list for a period of one year or less where it considers , on the basis of a substantiated assessment , that the conditions set by directive 2013 / 32 / eu for regarding a third country as safe country of origin are no longer met . for the purpose of this substantiated assessment , the commission should take into consideration a range of sources of information at its disposal including in particular , its annual progress reports for third countries designated as candidate countries by the european council , regular reports from the european external action service and the information from member states , the european asylum support office , the united nations high commissioner for refugees , the council of europe and other relevant international organisations . if , during the suspension period , it becomes clear from the information available that the situation in the third country has stabilised , the commission should be free to decide to lift the suspension of that country from the common list of safe countries of origin . the council and parliament must be kept informed of that decision . the commission should be able to extend the suspension of the presence of a third country from the eu common list for a period of maximum one year , where it has proposed an amendment to this regulation in order to remove this third country from the eu common list of safe countries of origin . 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 should regularly review the situation in third countries that are on the eu common list of safe countries of origin . in case of sudden change for the worse in the situation of a third country on the eu common list , 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 suspending the presence of this third country from the eu common list for a period of one year where it considers , on the basis of a substantiated assessment , that the conditions set by directive 2013 / 32 / eu for regarding a third country as safe country of origin are no longer met . for the purpose of this substantiated assessment , the commission should take into consideration a range of sources of information at its disposal including in particular , its annual progress reports for third countries designated as candidate countries by the european council , regular reports from the european external action service and the information from member states , the european asylum support office , the united nations high commissioner for refugees , the council of europe and other relevant international organisations . the commission should be able to extend the suspension of the presence of a third country from the eu common list for a period of maximum one year , where it has proposed an amendment to this regulation in order to remove this third country from the eu common list of safe countries of origin . 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 regularly review the situation in third countries that are on the eu common list of safe countries of origin . in case of sudden change for the worse in the situation of a third country on the eu common list , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union shall be delegated to the commission in respect of suspending the presence of this third country from the eu common list for a period of one year where it considers , on the basis of a substantiated assessment , that the conditions set by directive 2013 / 32 / eu for regarding a third country as safe country of origin are no longer met . for the purpose of this substantiated assessment , the commission shall take into consideration all sources of information at its disposal including in particular , its annual progress reports for third countries designated as candidate countries by the european council , regular reports from the european external action service and the information from member states , the european asylum support office , the united nations high commissioner for refugees , the council of europe and other relevant international organisations . the commission should be able to extend the suspension of the presence of a third country from the eu common list for a period of maximum one year , where it has proposed an amendment to this regulation in order to remove this third country from the eu common list of safe countries of origin . 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 .


### this regulation establishes an eu common list of third countries which shall be regarded as safe countries of origin within the meaning of directive 2013 / 32 / eu . ### this regulation establishes an eu common list of third countries which shall be regarded as safe countries of origin within the meaning of directive 2013 / 32 / eu so that nationals of those countries are guaranteed access to international protection procedures .


### any amendment of the eu common list of safe countries of origin shall be adopted in accordance with the ordinary legislative procedure . ### any amendment of the eu common list of safe countries of origin shall be adopted in accordance with the ordinary legislative procedure and immediately sent to the member states and the relevant third countries .


### in order to prevent a negative impact on the union market as a result of an increase in imports , the commission should adopt immediately applicable implementing acts where , in duly justified cases relating to the temporary suspension of the preferential tariffs under the anti - circumvention mechanism provided in the agreement , imperative grounds of urgency so require , ### in order to prevent a negative impact on the union market as a result of an increase in imports from georgia of the products in excess of the volume indicated in annex ii - c to the agreement , the commission should adopt immediately applicable implementing acts where , in duly justified cases relating to the temporary suspension of the preferential tariffs under the anti - circumvention mechanism provided in the agreement , imperative grounds of urgency so require ,


### the extended efsi should address remaining market failures and sub - optimal investment situations and continue to mobilise private sector financing in investments crucial for europe’s future job creation – including for the youth – , growth and competitiveness with strengthened additionality . they include investments in the areas of energy , environment and climate action , social and human capital and related infrastructure , healthcare , research and innovation , cross - border and sustainable transport , as well as the digital transformation . in particular , the contribution of operations supported by the efsi to achieving the union ' s ambitious targets set at the paris climate conference should be reinforced . energy interconnection priority projects and energy efficiency projects should also be increasingly targeted . in addition , efsi support to motorways should be avoided , unless it is needed to support private investment in transport in cohesion countries or in cross - border transport projects involving at least one cohesion country . for reasons of clarity , although they are already eligible , it should be explicitly laid down that projects in the fields of agriculture , fishery and aquaculture come within the general objectives eligible for efsi support . ### the extended efsi should address remaining market failures and sub - optimal investment situations and continue to mobilise private sector financing in investments crucial for europe’s future quality job creation – including for the youth , inclusive growth and competitiveness enhancing the social and employment impact , with strengthened additionality . they include investments in the areas of energy , environment and climate action , social and human capital and related infrastructure , social economy , healthcare , research and innovation , cross - border and sustainable transport , as well as the digital transformation . the contribution of operations supported by the efsi to achieve the union ' s ambitious targets set at the paris climate conference should be reinforced . energy interconnection priority projects and energy efficiency projects should also be increasingly targeted . moreover , social infrastructure related projects should be highly targeted . in addition , efsi support to motorways should be avoided , unless it is needed to support private investment in transport in cohesion countries or in cross - border transport projects involving at least one cohesion country . for reasons of clarity , although they are already eligible , it should be explicitly laid down that projects in the fields of agriculture , fishery and aquaculture come within the general objectives eligible for efsi support . given the high rates of poverty and social exclusion in europe , the operations supported by the efsi to tackling this issue should be reinforced .


### additionality , a key feature of the efsi , should be strengthened in the selection of projects . in particular , operations should only be eligible for efsi support if they address clearly identified market failures or sub - optimal investment situations . operations in infrastructure under the infrastructure and innovation window linking two or more member states , including e - infrastructure , should be considered additional given their inherent difficulty and their high added value for the union . ### additionality , a key feature of the efsi , should be strengthened in the selection of projects . in order to ensure that the entities that need to use the efsi guarantee fund are better represented , it would be advisable to allow for rotation on the steering board , and to include members of different services of the european commission , such as those responsible for transport and environment policies . in accordance with the additionality principle , operations should only be eligible if they address clearly identified market failures or sub - optimal investment situations . operations in infrastructure under the infrastructure and innovation window linking two or more member states , including e - infrastructure such as ertms , should be considered additional given their inherent difficulty and their high added value for the union .


### the eib and the eif should ensure that the final beneficiaries , including smes , are informed of the existence of efsi support , so as to enhance the visibility of the eu guarantee granted under regulation 2015 / 1017 . ### the eib and the eif should publicise the efsi in order to raise the profile of this important instrument . they should also ensure that the final beneficiaries , including smes , are informed of the existence of efsi support , so as to enhance the visibility of the eu guarantee granted under regulation 2015 / 1017 .


### decisions approving the use of the eu guarantee shall be public and accessible , and include the rationale for the decision , with particular focus on compliance with the additionality criterion . the publication shall not contain commercially sensitive information . in reaching its decision , the investment committee shall be supported by the documentation provided by the eib . ; ### decisions approving the use of the eu guarantee shall be made public and accessible without delay , and include the rationale for the decision based on the projects scoreboard , with particular focus on compliance with union policies , including the objective of smart , sustainable and inclusive growth , quality job creation and economic , social and territorial cohesion and with the additionality criterion . the publication shall not contain commercially sensitive information . in reaching its decision , the investment committee shall be supported by the documentation provided by the eib . ;


### leveraging local knowledge to facilitate efsi support across the union and contributing where possible to the objective of sectorial and geographical diversification of the efsi referred to in section 8 of annex ii by supporting the eib to originate operations ; ' ; ### leveraging regional and local knowledge , as well as supporting capacity building to facilitate efsi support across the union at all levels and contributing where possible to the objectives of economic , social and territorial cohesion , as well as of sectorial and geographical diversification of the efsi referred to in section 8 of annex ii by supporting the eib to originate operations , also in coordination with national and regional promotional banks ; ' ;


### providing advice on the combination of other sources of union funding with the efsi . ; ### providing advice on the combination of other sources of union funding with the efsi . ; and solution of practical problems in implementation of combining financing sources which occur because of different administrative requirements and financing sources in different instruments


### in order to achieve the objective referred to in paragraph 1 and to facilitate the provision of advisory support at local level , the eiah shall seek to use the expertise of the eib , the commission , national promotional banks or institutions , and the managing authorities of the european structural and investment funds . ; ### in order to achieve the objective referred to in paragraph 1 and to facilitate the provision of advisory support at regional and local level , the eiah shall seek to use the expertise of the eib , the commission , the national and regional promotional banks or institutions , and the managing authorities of the european structural and investment funds . in order to facilitate the crowding - in of private investors , interaction among the eiah , the eipp , the eib , and national and regional promotional banks or institutions shall be strengthened . ;


### the union shall contribute up to a maximum of eur 20 000 000 per annum towards covering the costs of eiah operations until 31 december 2020 for the services provided by the eiah under paragraph 2 which are in addition to those already available under other union programmes , insofar as those costs are not covered by the remaining amount from fees referred to in paragraph 4 . ### paragraph 7 is replaced by following : ‘ 7 . an annual reference amount of eur 20 000 000 shall be made available from the general budget of the union to contribute towards covering the costs of eiah operations until 31 december 2020 for the services provided by the eiah under paragraph 2 which are in addition to those already available under other union programmes , insofar as those costs are not covered by the remaining amount from fees referred to in paragraph 4 . ’


### the plan shall aim at contributing to the objectives of the common fisheries policy listed in article 2 of regulation no 1380 / 2013 and in particular : ### the plan shall aim at contributing to the objectives of the common fisheries policy listed in article 2 of regulation no 1380 / 2013 and in particular the objectives outlined in article 2 . 2 , article 9 . 1 and article 9 . 2 of the same regulation :


### article 6 measures in case of threat to plaice , flounder , turbot and brill when scientific advice states that the conservation of any of the baltic stocks of plaice , flounder , turbot or brill is under threat , the commission shall be empowered to adopt delegated acts in accordance with article 15 on specific conservation measures concerning the stock under threat and regarding any of the following : adaptation of fishing capacity and fishing effort ; technical measures , including characteristics of fishing gear , in particular mesh size , twine thickness , size of the gear ; use of the fishing gear , in particular immersion time , depth of gear deployment ; prohibition or limitation to fish in specific areas ; prohibition or limitation to fish during specific time periods ; minimum conservation reference size . 2 . the measures referred to in paragraph 1 shall aim at achieving the objective set out in article 3 and be based on scientific advice . 3 . the member states concerned may submit joint recommendations in accordance with article 18 of regulation no 1380 / 2013 for specific conservation measures as referred to in paragraph 1 . ### article 6 technical conservation measures for plaice , flounder , turbot and brill when scientific advice indicates that remedial measures are needed to ensure that the baltic stocks of plaice , flounder , turbot or brill are managed in accordance with the precautionary approach , the commission shall be empowered to adopt delegated acts in accordance with article 15 on specific conservation measures for by - catches of plaice , flounder , turbot and brill and regarding the following technical measures : characteristics of fishing gear , in particular mesh size , twine thickness , size of the gear ; use of the fishing gear , in particular immersion time , depth of gear deployment ; prohibition or limitation to fish in specific areas ; prohibition or limitation to fish during specific time periods ; minimum conservation reference size . 2 . the measures referred to in paragraph 1 shall aim at achieving the objective set out in article 3 and be based on scientific advice . 3 . the member states concerned may submit joint recommendations in accordance with article 18 of regulation no 1380 / 2013 for specific conservation measures as referred to in paragraph 1 . 4 . the commission shall review the delegated acts referred to in paragraph 1 one year after their adoption , and thereafter every year .


### specifications of target species and mesh sizes laid down in annexes ii and iii referred to in articles 3 and 4 of regulation no 2187 / 2005 ; ### specifications of target species , mesh sizes and minimum conservation reference sizes laid down in annexes ii , iii and iv to regulation no 2187 / 2005 and referred to in articles 3 , 4 and 14 of that regulation ;


### by way of derogation from article 17 of regulation no 1224 / 2009 , the prior notification obligation laid down in that article shall apply to masters of union fishing vessels of eight metres overall length or more retaining on board at least 300 kg of cod or two tons of pelagic stocks . ### by way of derogation from article 17 of regulation no 1224 / 2009 , the prior notification obligation laid down in that article shall apply to : masters of union fishing vessels of eight metres overall length or more retaining on board at least 300 kilograms of cod ; masters of union fishing vessels of twelve metres overall length or more retaining on board at least two tonnes of pelagic stocks .


### article 14 evaluation of the plan the commission shall ensure an evaluation of the impact of this plan on the stocks covered by this regulation and on the fisheries exploiting those stocks , in particular to take account of changes in scientific advice , six years after the entry into force of the plan and , thereafter , every six years . the commission shall submit the results of these evaluations to the european parliament and council . ### article 14 evaluation of the plan the commission shall carry out an evaluation of the impact of this plan , including any delegated acts adopted under articles 8 , 9 or 9a , on the stocks covered by this regulation and on the fisheries exploiting those stocks , in particular to take account of the most recent scientific advice , three years after the entry into force of the plan and , thereafter , every five years . the commission shall submit the results of these evaluations to the european parliament and the council and make such legislative proposals as may be appropriate .


### articles 20 and 21 of regulation no 2187 / 2005 are deleted . ### regulation no 2187 / 2005 is amended as follows : article 13 and articles 20 and 21 are deleted . 2 . in annex iv , in the column headed ' minimum size ' , the words ' 38 cm ' in respect of the minimum conservation reference size for cod shall be replaced by ' 35 cm ' .


### the financial management of the guarantee fund should be transferred from the eib to the commission , which has an established practice of managing similar investments . by taking over the asset management of the guarantee fund , the commission should be able to streamline and consolidate its asset management activities , building on existing structures and a good track record . ### the possibility of transferring the financial management of the guarantee fund from the eib to the commission should be evaluated in terms of associated costs and benefits in order to ensure maximum efficiency of the use of union financial resources in view of the post - 2020 multiannual financial framework .


### there is a need to provide business statistics structured by sector of activity , in order to measure the productivity of businesses in the union . in particular , there is an increasing demand of statistics on the services sector , which is the most dynamic sector of modern economies , especially in terms of that sector ' s potential for growth and employment creation and taking into account the relations with the manufacturing sector . statistics on trade in services are essential for monitoring the functioning of the internal market for services and assessing the impact of barriers on trade in services . ### there is a need to provide business statistics structured by sector of activity , in order to measure the productivity of businesses in the union . in particular , there is an increasing demand of statistics on the services sector , which is the most dynamic sector of modern economies , especially in terms of that sector ' s potential for growth and employment creation and taking into account the relations with the manufacturing sector . this will also be the case for creative and cultural industries as proposed in the european parliament resolution on a coherent eu policy for cultural and creative industries1a . statistics on trade in services are essential for monitoring the functioning of the internal market for services and assessing the impact of barriers on trade in services . __________________ 1a p8_ta - prov0486 .


### in order to take account of economic and technical developments , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of the detailed topics set out in annexes i and ii as well as the coverage rate for intra - union exports of goods . the commission should also have the power to supplement the detailed topics with subjects and characteristics for the dynamic business statistics on ict , innovation and global value chains and exact information to be provided by tax authorities and custom authorities . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 20161 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and council receive all documents at the same time as member states ' experts , and their experts have systematic access to meetings of commission expert groups dealing with the preparation of delegated acts . __________________ oj l 123 , 12 . 5 . 2016 , p . 1 . ### in order to take account of economic and technical developments , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of the detailed topics set out in annexes i and ii as well as the coverage rate for intra - union exports of goods . the commission should also have the power to supplement the detailed topics with subjects and characteristics for the dynamic business statistics on ict , innovation and global value chains , to supplement the register detailed topics with descriptive details , to supplement the statistical data elements for the micro - data collected through surveys on intra - union trade in goods to be provided to the member state of import and to supplement exact information to be provided by tax authorities and custom authorities . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 20161 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and council receive all documents at the same time as member states ' experts , and their experts have systematic access to meetings of commission expert groups dealing with the preparation of delegated acts . __________________ oj l 123 , 12 . 5 . 2016 , p . 1 .


### in order to ensure uniform conditions for the technical implementation of certain elements of requirements including for business registers , the format , security and confidentiality measures and the procedure for the exchange of confidential data for the purpose of the european network of statistical business registers , the data and metadata transmission , data quality and metadata reports and derogations implementing powers should be conferred on the commission . with the same purpose additional implementing powers should be conferred on the commission with regards to the modalities of and the format , security and confidentiality measures and the procedure for the exchange of confidential data for the purpose of the intra - union trade in goods statistics , the specifications of the relevant metadata , the timetable , the modalities of the collection and compilation of the statistical information on intra - union exports of goods provided to the member state of import , the modalities for the application of the coverage rate of the total intra - union exports of goods , the statistical data elements for the micro - data collected through surveys on intra - union trade in goods to be provided to the member state of import and the related simplifications . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and the council1 . __________________ regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers . ### in order to ensure uniform conditions for the technical implementation of certain elements of requirements including for business registers , the format , security and confidentiality measures and the procedure for the exchange of confidential data for the purpose of the european network of statistical business registers , the data and metadata transmission , data quality and metadata reports and derogations implementing powers should be conferred on the commission . with the same purpose additional implementing powers should be conferred on the commission with regards to the modalities of and the format , security and confidentiality measures and the procedure for the exchange of confidential data for the purpose of the intra - union trade in goods statistics , the specifications of the relevant metadata , the timetable , the modalities of the collection and compilation of the statistical information on intra - union exports of goods provided to the member state of import , the modalities for the application of the coverage rate of the total intra - union exports of goods , and the detailed arrangements for the simplification of the statistical data elements for the micro - data collected through surveys on intra - union trade in goods to be provided to the importing member state . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and the council1 . __________________ regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers .


### the european network of statistical business registers shall cover the national business registers and the eurogroups register , as well as the exchanges between them . ### the european network of statistical business registers shall cover the national statistical business registers and the eurogroups register , as well as the exchanges between them in accordance with article 10 .


### the commission shall be empowered to adopt delegated acts in accordance with article 21 for the purpose of amending the detailed topics specified in annex i and for the purpose of specifying subjects and characteristics covered by the detailed topics of innovation and ict usage and e - commerce and global value chains . ### the commission shall be empowered to adopt delegated acts in accordance with article 21 for the purpose of amending the detailed topics specified in annex i and for the purpose of supplementing subjects and characteristics covered by the detailed topics of innovation and ict usage and e - commerce and global value chains .


### delegated acts are adopted at least 15 months before the end of the reference period of the data except for the topics of ' innovation ' and ' ict usage and e - commerce ' for which the delegated acts shall be adopted at least six and twelve months respectively before the end of the reference period of the data . ### delegated acts are adopted no later than six months before the beginning of the reference period of the data except for the topics of “innovation” and “ict usage and e - commerce” for which the delegated acts shall be adopted at least three months respectively before the beginning of the reference period of the data .


### when exercising the powers referred to in paragraph 1 with regard to the simplifications , the commission shall take into account the size and importance of the business economies , in accordance with the principle of proportionality , in order to alleviate the burden on enterprises . in addition , the commission shall ensure that the input needed for compiling the accounting frameworks of national and regional accounts according to regulation no 549 / 2013 and of balance of payments statistics according to regulation no 184 / 2005 is maintained . implementing acts , except for those that regulate the first implementation of this regulation , shall be adopted at least 15 months before the end of the reference period of the data for the topics listed in annex i . for the topics ' innovation ' and ' ict usage and e - commerce ' the implementing acts shall be adopted at least six and twelve months respectively before the end of the reference period of the data . ### when exercising the powers referred to in paragraph 1 with regard to the simplifications , the commission shall take into account the size and importance of the business economies , in accordance with the principle of proportionality , in order to alleviate the burden on enterprises . in addition , the commission shall ensure that the input needed for compiling the accounting frameworks of national and regional accounts according to regulation no 549 / 2013 and of balance of payments statistics according to regulation no 184 / 2005 is maintained . implementing acts , except for those that regulate the first implementation of this regulation , shall be adopted at least six months before the beginning of the reference period of the data for the topics listed in annex i . for the topics ' innovation ' and ' ict usage and e - commerce ' the implementing acts shall be adopted at least three months before the beginning of the reference period of the data .


### national statistical business registers shall be the authoritative source for national register populations . the eurogroups register shall be the authoritative source for the european statistical system register population for business statistics requiring the coordination of cross - border information . ### national statistical business registers shall be the authoritative source for national statistical register populations . the eurogroups register shall be the authoritative source for the european statistical system of register population for business statistics requiring the coordination of cross - border information .


### the commission shall be empowered to adopt delegated acts in accordance with article 21 to amend the register detailed topics included in annex iii to relevant technical and economic developments and new user needs . ### the commission shall be empowered to adopt delegated acts in accordance with article 21 to amend the register detailed topics included in annex iii to relevant technical and economic developments and new user needs and to add the descriptive details for each of the register detailed topics .


### transmission of confidential data between national statistical authorities and the commission shall take place to the extent that such transmission is necessary for the production of european statistics . any further transmission must be explicitly authorised by the national authority that collected the data . ### transmission of confidential data between national statistical authorities and the commission shall take place to the extent that such transmission is necessary exclusively for statistical purposes for the production of european statistics . any further transmission must be explicitly authorised by the national authority that collected the data .


### the commission shall be empowered to adopt implementing acts in accordance with the examination procedure referred to in article 22 for the purpose of specifying the statistical data elements referred to in points to , and for specifying the list of statistical data elements applicable for the specific goods or movements and the data compiled by using the particulars of customs declarations referred to in points and of article 12 . ### the commission shall be empowered to adopt delegated acts in accordance with article 21 for the purpose of supplementing the statistical data elements referred to in points to , and for supplementing the list of statistical data elements applicable for the specific goods or movements and the data compiled by using the particulars of customs declarations referred to in points and of article 12 .


### the commission shall be empowered to adopt implementing acts specifying the modalities , content and deadlines for the transmission of the metadata and quality reports . these implementing acts shall be adopted in accordance with the examination procedure referred to in article 22 . ### the commission shall be empowered to adopt implementing acts specifying the modalities , content and deadlines for the transmission of the metadata and quality reports . these implementing acts shall be adopted in accordance with the examination procedure referred to in article 22 and shall not impose significant additional burden or cost on the member states or on the respondent .


### at the request of the commission , member states shall provide the additional information necessary to evaluate the quality of the statistical information . ### at the request of the commission , member states shall provide the additional information necessary to evaluate the quality of the statistical information . such commission requests shall not impose a significant additional burden or significant additional costs on the member states .


### the power to adopt delegated acts referred to in articles 5 , 6 , 9 and 12 shall be conferred on the commission for an indeterminate period of time . ### the power to adopt delegated acts referred to in articles 5 , 6 , 9 , 12 and 13 shall be conferred on the commission for a period of five years . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the power to adopt delegated acts referred to in articles 5 , 6 , 9 and 12 shall be conferred on the commission for an indeterminate period of time . ### the power to adopt delegated acts referred to in articles 5 , 6 , 9 and 12 shall be conferred on the commission for a period of five years after the entry into force of this regulation .


### the delegation of power referred to in articles 5 , 6 , 9 and 12 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 . ### the delegation of power referred to in articles 5 , 6 , 9 , 12 and 13 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 pursuant to articles 5 , 6 , 9 and 12 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 the council . ### a delegated act adopted pursuant to articles 5 , 6 , 9 , 12 and 13 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 the council .


### where the application of this regulation in a national statistical system of a member state necessitates major adaptations , the commission may grant , by means of implementing acts , derogations from its application for a maximum duration of three years , provided that these derogations do not hamper either the comparability of member states ' data or the calculation of the required timely and representative european aggregates . ### where the application of this regulation in a national statistical system of a member state necessitates major adaptations , the commission may grant , by means of implementing acts , derogations from its application for a maximum duration of three years .


### the public sector in the member states collects , produces , reproduces and disseminates a wide range of information in many areas of activity , such as social , economic , geographical , weather , tourist , business , patent and educational information . documents produced by public sector bodies of executive , legislative or judicial nature constitute a vast , diverse and valuable pool of resources that can benefit the knowledge economy . ### the public sector in the member states collects , produces , reproduces and disseminates a wide range of information in many areas of activity , such as social , economic , cultural , geographical , weather , tourist , business , patent and educational information . documents produced by public sector bodies of executive , legislative or judicial nature constitute a vast , diverse and valuable pool of resources that can benefit the knowledge economy .


### the directive lays down an obligation for member states to make all documents re - usable unless access is restricted or excluded under national rules on access to documents and subject to the other exceptions laid down in this directive . the directive builds on the existing access regimes in the member states and does not change the national rules for access to documents . it does not apply in cases in which citizens or companies can , under the relevant access regime , only obtain a document if they can prove a particular interest . at union level , articles 41 and 42 of the charter of fundamental rights of the european union recognise the right of any citizen of the union and any natural or legal person residing or having its registered office in a member state to have access to european parliament , council and commission documents . public sector bodies should be encouraged to make available for re - use any documents held by them . public sector bodies should promote and encourage re - use of documents , including official texts of a legislative and administrative nature in those cases where the public sector body has the right to authorise their re - use . ### the directive lays down an obligation for member states to make all documents re - usable without prejudice to exceptions laid down in this directive . the directive builds on the access regimes currently in force in the member states . in that regard , it does not change the national rules for access to documents , nor does it establish specific access rights or obligations to publish information , which should remain a decision at the discretion of member states . it does not apply in cases in which citizens or companies can , under the relevant access regime , only obtain a document if they can prove a particular interest . at union level , articles 41 and 42 of the charter of fundamental rights of the european union recognise the right of any citizen of the union and any natural or legal person residing or having its registered office in a member state to have access to european parliament , council and commission documents . public sector bodies should be encouraged to make available for re - use any documents held by them . public sector bodies should promote and encourage re - use of documents , including official texts of a legislative and administrative nature in those cases where the public sector body has the right to authorise their re - use .


### a document should be considered to be in a machine - readable format if it is in a file format that is structured in such a way that software applications can easily identify , recognise and extract specific data from it . data encoded in files that are structured in a machine - readable format should be considered to be machine - readable data . machine - readable formats can be open or proprietary ; they can be formal standards or not . documents encoded in a file format that limits automatic processing , because the data cannot , or cannot easily , be extracted from them , should not be considered to be in a machine - readable format . member states should where possible and appropriate encourage the use of open , machine - readable formats . ### a document should be considered to be in a machine - readable format if it is in a file format that is structured in such a way that software applications can easily identify , recognise and , in a technologically neutral manner , extract specific data from it . data encoded in files that are structured in a machine - readable format should be considered to be machine - readable data . machine - readable formats can be open or proprietary ; they can be formal standards or not . documents encoded in a file format that limits automatic processing , because the data cannot , or cannot easily , be extracted from them , should not be considered to be in a machine - readable format . member states should where possible and appropriate encourage the use of open , machine - readable formats .


### charges for the re - use of documents constitute an important market entry barrier for start - ups and smes . documents should therefore be made available for re - use without charges and , where charges are necessary , they should in principle be limited to the marginal costs . in exceptional cases , the necessity of not hindering the normal running of public sector bodies that are required to generate revenue to cover a substantial part of their costs relating to the performance of their public tasks should be taken into consideration . the role of public undertakings in a competitive economic environment should also be acknowledged . in such cases , public sector bodies and public undertakings should therefore be able to charge above marginal costs . those charges should be set according to objective , transparent and verifiable criteria and the total income from supplying and allowing re - use of documents should not exceed the cost of collection , production , reproduction and dissemination , together with a reasonable return on investment . where applicable , the costs of anonymisation of personal data or of commercially sensitive information should also be included in the eligible cost . the requirement to generate revenue to cover a substantial part of the public sector bodies’ costs relating to the performance of their public tasks or the scope of the services of general interest entrusted with public undertakings does not have to be a legal requirement and may stem , for example , from administrative practices in member states . such a requirement should be regularly reviewed by the member states . ### charges for the re - use of documents constitute an important market entry barrier for start - ups and smes , in particular in the cultural and creative sectors . documents should therefore be made available for re - use without charges and , where charges are necessary , they should in principle be limited to the marginal costs . marginal costs consist of the extra costs occurring from the digitisation , storage and management of documents , as well as the costs of digital mass storage , the additional effort to render data machine readable and the extra burden deriving from infrastructure measures . in exceptional cases , the necessity of not hindering the normal running of public sector bodies that are required to generate revenue to cover a substantial part of their costs relating to the performance of their public tasks should be taken into consideration . the role of public undertakings in a competitive economic environment should also be acknowledged . in such cases , public sector bodies and public undertakings should therefore be able to charge above marginal costs . those charges should be set according to objective , transparent and verifiable criteria and the total income from supplying and allowing re - use of documents should not exceed the cost of collection , production , reproduction and dissemination , together with a reasonable return on investment . where applicable , the costs of anonymisation of personal data or of commercially sensitive information should also be included in the eligible cost . the requirement to generate revenue to cover a substantial part of the public sector bodies’ costs relating to the performance of their public tasks or the scope of the services of general interest entrusted with public undertakings does not have to be a legal requirement and may stem , for example , from administrative practices in member states . such a requirement should be regularly reviewed by the member states .


### one of the principal aims of the establishment of the internal market is the creation of conditions conducive to the development of union - wide services . libraries , museums and archives hold a significant amount of valuable public sector information resources , in particular since digitisation projects have multiplied the amount of digital public domain material . these cultural heritage collections and related metadata are a potential base for digital content products and services and have a huge potential for innovative re - use in sectors such as learning and tourism . other types of cultural establishments , including the archives that are part of those establishments , should remain outside the scope because of their ‘ performing arts’ specificity and the fact that almost all of their material is subject to third - party intellectual property rights and would therefore remain outside the scope of that directive . ### one of the principal aims of the establishment of the internal market is the creation of conditions conducive to the development of union - wide services . libraries , museums and archives hold a significant amount of valuable public sector information resources . the re - use of documents held by such institutions possesses substantial social and economic potential for cultural and creative industries , as well as to society , in particular since digitisation projects have multiplied the amount of digital public domain material , which is accessible on platforms such as europeana . these cultural heritage collections and related metadata are a potential base for digital content products and services and have a huge potential for innovative re - use not only for the cultural and creative sectors , but also in other sectors such as learning and tourism . other types of cultural establishments , including the archives that are part of those establishments , should remain outside the scope because of their ‘ performing arts’ specificity and the fact that almost all of their material is subject to third - party intellectual property rights and would therefore remain outside the scope of that directive .


### existing documents held by public sector bodies of the member states ; ### publicly accessible documents held by public sector bodies of the member states ;


### existing documents held by public undertakings active in the areas defined in directive 2014 / 25 / eu of the european parliament and of the council42 and by public undertakings acting as public service operators pursuant to article 2 of regulation no 1370 / 2007 of the european parliament and of the council43 , public undertakings acting as air carriers fulfilling public service obligations pursuant to article 16 of regulation no 1008 / 2008 of the european parliament and of the council44 , and public undertakings acting as community shipowners fulfilling public service obligations pursuant to article 4 of council regulation no 3577 / 9245 . __________________ 42 directive 2014 / 25 / eu of the european parliament and of the council of 26 february 2014 on procurement by entities operating in the water , energy , transport and postal services sectors and repealing directive 2004 / 17 / ec . 43 regulation no . 1370 / 2007 of the european parliament and of the council of 23 october 2007on public passenger transport services by rail and by road and repealing council regulations nos 1191 / 69 and 1107 / 70 . 44 regulation no 1008 / 2008 of the european parliament and of the council of 24 september 2008 on common rules for the operation of air services in the community . 45 council regulation no 3577 / 92 of 7 december 1992 applying the principle of freedom to provide services to maritime transport within member states . ### publicly accessible documents held by public undertakings active in the areas defined in directive 2014 / 25 / eu of the european parliament and of the council42 and by public undertakings acting as public service operators pursuant to article 2 of regulation no 1370 / 2007 of the european parliament and of the council43 , public undertakings acting as air carriers fulfilling public service obligations pursuant to article 16 of regulation no 1008 / 2008 of the european parliament and of the council44 , and public undertakings acting as community shipowners fulfilling public service obligations pursuant to article 4 of council regulation no 3577 / 9245 . __________________ 42 directive 2014 / 25 / eu of the european parliament and of the council of 26 february 2014 on procurement by entities operating in the water , energy , transport and postal services sectors and repealing directive 2004 / 17 / ec . 43 regulation no . 1370 / 2007 of the european parliament and of the council of 23 october 2007on public passenger transport services by rail and by road and repealing council regulations nos 1191 / 69 and 1107 / 70 . 44 regulation no 1008 / 2008 of the european parliament and of the council of 24 september 2008 on common rules for the operation of air services in the community . 45 council regulation no 3577 / 92 of 7 december 1992 applying the principle of freedom to provide services to maritime transport within member states .


### documents held by public undertakings , produced outside the scope of the provision of services in the general interest as defined by law or other binding rules in the member state ; ### documents held by public undertakings , produced outside the scope of the provision of services in the general interest as defined by law or other binding rules in the member state or in the absence of such rules , in accordance with standard administrative practice currently in force ;


### the re - use of high value datasets , the list of which shall be defined in accordance with article 13 , and of research data referred to in point of article 1 shall be free of charge for the user . ### the re - use of high value datasets , the list of which shall be defined in accordance with article 13 , and of research data referred to in point of article 1 shall be free of charge or at a reduced cost for the user .


### new psychoactive substances can pose serious cross border threats to health which makes necessary to enhance monitoring , early warning and combating of those threats . ### new psychoactive substances , which may have numerous commercial and industrial uses , as well as scientific uses , can pose serious cross border threats to health , in particular due to their diversity and the speed with which they have been appearing . the rapid growth of the market of those novel products continues to be challenging , making it necessary to enhance monitoring and early warning systems , to assess their health , safety and social risks in order to develop responses such as risk reduction measures in order to combat those threats .


### new psychoactive substances that pose health and social risks across the union should be addressed at the union level . this regulation has therefore to be read in conjunction with council framework decision 2004 / 757 / jha15 [ as amended by directive … / … ] since both acts are designed to replace the mechanism established by council decision 2005 / 387 / jha . __________________ 15 council framework decision 2004 / 757 / jha of 25 october 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking . ### new psychoactive substances that pose health , safety and social risks across the union should be addressed at the union level . this regulation has therefore to be read in conjunction with council framework decision 2004 / 757 / jha15 [ as amended by directive … / … ] since both acts are designed to replace the mechanism established by council decision 2005 / 387 / jha . __________________ 15 council framework decision 2004 / 757 / jha of 25 october 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking .


### any union action on new psychoactive substances should be based on scientific evidence . ### any union action on new psychoactive substances should be based on scientific evidence or on sufficient data on the risks that the new psychoactive substances pose . given that in some cases new psychoactive substances could be so novel to the field that , at least initially , there would be very limited evidence from scientific research on public health risks , it is necessary to undertake rapid risk assessment procedures at union level .


### each member state shall ensure that its reitox national focal points and the europol national unit provide timely and without any undue delay to the centre and europol the available information on new psychoactive substances . the information shall be related to the detection and identification , use and patterns of use , potential and identified risks , manufacture , extraction , distribution , trafficking , commercial , as well as medical and scientific use of these substances . ### each member state shall ensure that its national focal points within the european information network on drugs and drug addiction and the europol national units provide timely and without any undue delay to the centre and europol the available information on what appears to be a new psychoactive substance or mixture . the information shall be related to the detection and identification , use and patterns of use , prevalence of use , potential and identified risks , manufacture , extraction , distribution and distribution channels , trafficking and cross - border global supply chains , commercial , as well as medical and scientific use of these substances .


### the centre , in cooperation with europol , shall collect , analyse , assess , and communicate this information in a timely manner to member states with a view to providing member states with any information required for the purposes of early warning and for the purposes of allowing the centre to draw up the initial report or the combined initial report pursuant to article 5b . ### the centre , in cooperation with europol , shall collect , analyse , assess , and communicate this information in a timely manner to member states and to the commission , with the purpose to providing member states and the commission with any information required for developing early warning models and for the purposes of allowing the centre to draw up the initial report or the combined initial report pursuant to article 5b .


### where the centre , the commission or the council , acting by a simple majority of member states , consider that the information shared on a new psychoactive substance collected pursuant to article 5a in one or more member states gives rise to concerns that the new psychoactive substance may pose health or social risks at the union level , the centre shall draw up an initial report on the new psychoactive substance . ### where the centre , the commission or the council , acting by a simple majority of member states , consider that the information shared on a new psychoactive substance collected pursuant to article 5a in one or more member states gives rise to concerns that the new psychoactive substance may pose health , safety or social risks at the union level , the centre shall draw up without undue delay an initial report on the new psychoactive substance .


### the centre shall request europol to provide information on the involvement of criminal groups in the manufacture and distribution of the new psychoactive substance , and in any use of the new psychoactive substance . ### the centre shall request europol to provide , without undue delay , information on the involvement of criminal groups in the manufacture , distribution and distribution channels of the new psychoactive substance , and in any use of the new psychoactive substance and other relevant information on the new psychoactive substance .