### the right to written information about rights on arrest where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he is deprived of his liberty . 2 . the letter of rights shall be drafted in simple language and shall include at least that information referred to in article 3 . annex i to this directive contains an indicative model of such a letter . 3 . member states shall ensure that , where the suspected or accused person does not speak or understand the language of the proceedings , he receives the letter of rights in a language he understands . member states shall ensure that a mechanism is in place to convey the information to a suspected or accused person who is partially sighted or cannot read . where the suspected or accused person is a child , the information contained in the letter of rights shall also be provided orally in a manner adapted to the child ' s age , level of maturity and intellectual and emotional capacities . 4 . where a letter of rights is not available in the appropriate language , the suspected or accused person shall be informed of his rights orally in a language he understands . a letter of rights in a language he understands shall then be given to him without undue delay . ### the right to written information about rights on arrest or upon detention where a person is arrested or detained by the competent authorities of a member state in the course of criminal proceedings , he or she shall be promptly provided with information about his or her procedural rights in writing . he or she shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he or she is deprived of his liberty . 2 . the letter of rights shall be drafted in simple language and shall include at least that information referred to in article 3 and 2 . the letter of rights shall contain at least the elements set out in annex i to this directive . 2a . in addition of to the information to be given under article 3 , the person arrested or detained shall be informed about the following : for how many hours or days he or she may be deprived of liberty before being brought before a judicial authority ; how to challenge the arrest and how to obtain a review of his or her detention ; the maximum period of pre - trial detention applicable to his or her case ; the right to contact family , friends , and consular officials ; the right to medical care ; where applicable , the right to apply for supervision measures as an alternative to provisional detention . 3 . member states shall ensure that , where the suspected or accused person does not speak or understand the language of the proceedings , he or she receives the letter of rights in a language he or she understands . member states shall ensure that a mechanism is in place to convey the information to a suspected or accused person who is partially sighted or cannot read . where the suspected or accused person is vulnerable due to age , incapacity or any other reason , the information contained in the letter of rights shall also be provided orally in a manner adapted to the person ' s age , level of maturity and intellectual and emotional capacities . 4 . where a letter of rights is not available in the appropriate language , the suspected or accused person shall be informed of his or her rights orally by a qualified interpreter in a language he or she understands in accordance with directive 2010 / 64 / eu . a letter of rights in a language he understands shall then be given to him or her without undue delay .


### – if you do not consent to be sent to the member state seeking you , you are entitled to go before a judge and to explain why you don ' t consent . ### – if you do not agree to be surrendered you have the right to go before a judge for a hearing and to explain why you do not agree . – the judge will decide whether the european arrest warrant has been correctly , legally and appropriately issued and whether you should be sent to the country which is seeking your surrender . – you have the right to be represented by a lawyer at this hearing . – if you are not able to afford a lawyer , you must be provided with information about how to obtain legal assistance .


### member states shall ensure that any person subject to proceedings for the execution of a european arrest warrant receives an appropriate letter of rights setting out the rights of that person as laid down in the framework decision 2002 / 584 / jha . annex ii to this directive contains an indicative model of such letter . ### member states shall ensure that any person subject to proceedings for the execution of a european arrest warrant receives an appropriate letter of rights setting out the rights of that person as laid down in the framework decision 2002 / 584 / jha . the letter of rights shall be drafted in simple language and shall contain at least the elements set out in annex ii to this directive .


### member states shall ensure that any person who is suspected or accused of having committed a criminal offence is provided promptly with information on his procedural rights in simple and accessible language . ### the competent authorities shall ensure that any person who is suspected or accused of having committed a criminal offence is provided promptly and in any event before questioning takes place with information on his procedural rights at least in writing and in simple and accessible language .


### where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he is deprived of his liberty . ### where a person is deprived of liberty by the authorities of a member state in the course of criminal proceedings , he / she shall immediately be provided with information about his procedural rights in writing . he / she shall be given an opportunity to read the letter of rights and be allowed to keep it in his / her possession throughout the time during which he / she is deprived of his / her liberty . this provision shall apply to all cases where persons are deprived of liberty by public authorities .


### this directive applies from the time a person is made aware by the competent authorities of a member state , by official notification or otherwise , that he is suspected or accused of having committed a criminal offence until the conclusion of the proceedings , which is understood to mean the final determination of the question whether the suspected or accused person has committed the offence , including , where applicable , sentencing and the resolution of any appeal . ### this directive applies from the time a person is made aware by the competent authorities of a member state , by official notification or otherwise , that he or she is suspected or accused of having committed a criminal offence until the conclusion of the proceedings , which is understood to mean the final determination of the question whether the suspected or accused person has committed the offence , including , where applicable , sentencing and the resolution of any appeal .


### adequate training on procedural rights of suspected and accused persons should be provided to the relevant officials in member states . ### appropriate and effective training on procedural rights of suspected and accused persons should be provided to the relevant officials in member states .


### to be informed of your right to agree to surrender ### to decide whether or not you agree to be surrendered to another country


### the information referred to in paragraph 1 shall include as a minimum : – the right of access to a lawyer , where necessary free of charge , – the right to be informed of the charge and , where appropriate , to be given access to the case - file , – the right to interpretation and translation , – the right to be brought promptly before a court if the suspected or accused person is arrested . ### the information referred to in paragraph 1 shall include as a minimum : – the right of access to a lawyer , where necessary free of charge , – the right to be informed of the charge and , where appropriate , to be given access to evidentiary materials of the case , – the right to interpretation and translation , – the right to be brought promptly before a court if the suspected or accused person is arrested , – the right to remain silent , and any implications there may be in exercising that right under national law .


### your right to agree to surrender – you have the right to agree to being surrendered under a european arrest warrant . this should speed the procedure up . – if you agree to be surrendered , it may be difficult to change your decision at a later stage . you should speak to a lawyer before deciding whether or not to agree to surrender . ### surrender – you can agree to be surrendered to the country seeking your surrender under a european arrest warrant . you do not have to agree to be surrendered . – if you agree to be surrendered , it may be difficult to change your decision at a later stage . – you should speak to a lawyer before deciding whether or not to agree to surrender . there are particular grounds you can rely on to prevent surrender . a lawyer can assist you in deciding whether they apply in your case .


### member states shall ensure that any person subject to proceedings for the execution of a european arrest warrant receives an appropriate letter of rights setting out the rights of that person as laid down in the framework decision 2002 / 584 / jha . annex ii to this directive contains an indicative model of such letter . ### member states shall ensure that any person subject to proceedings for the execution of a european arrest warrant receives an appropriate letter of rights setting out all of the rights of that person as laid down in the framework decision 2002 / 584 / jha . the letter of rights shall be drafted in simple language and shall contain at least the elements set out in annex ii to this directive .


### to know for how long you can be detained ### to know for how long you can be detained , to a regular review of your detention and to provisional release


### indicative model letter of rights for suspected and accused persons on arrest : ### model letter of rights for suspected and accused persons on arrest :


### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a characterising flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided36 . ### the likelihood of diverging regulation is further increased by concerns over tobacco products , including smokeless tobacco products , having a flavour other than tobacco , which may facilitate uptake of tobacco consumption or affect consumption patterns . for example , in many countries , sales of mentholated products gradually increased even as smoking prevalence overall declined . a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people . measures introducing unjustified differences of treatment between flavoured cigarettes should be avoided36 .


### member states shall prohibit the use of the following additives in tobacco products : ### annex - i shall not contain the following additives in tobacco products :


### member states shall , based on scientific evidence , prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product . ### annex - i shall not contain , based on scientific evidence , additives in quantities that increase at the stage of consumption the toxic or addictive effect of a tobacco product .


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


### any effects concerning the health and safety of workers at particular risk such as workers who have declared to the employer that they wear an active implanted medical device and women who have declared that they are pregnant ; ### any effects concerning the health and safety of workers at particular risk such as workers who wear an active or passive implanted medical device , workers equipped with portable medical devices and pregnant women ;


### exposure limit values and action values for both electric and magnetic fields in the frequency range from 100 khz to 300 ghz shall be as set out in annex iii . ### action values for electromagnetic fields shall be as set out in annex ii .


### pursuant to article 15 of directive 89 / 391 / eec , the employer shall adapt the measures referred to in this article and in annexes ii and iii to the requirements of workers at particular risk . ### pursuant to article 15 of directive 89 / 391 / eec , the employer shall adapt the measures referred to in this article to the requirements of workers at particular risk and individual risks assessments as appropriate .


### any effects concerning the health and safety of workers at particular risk such as workers who have declared to the employer that they wear an active implanted medical device and women who have declared that they are pregnant ; ### any effects concerning the health and safety of workers at particular risk , in particular workers who wear an active or passive implanted medical device , workers who wear body worn medical devices , workers with poor immune systems and women who are pregnant ;


### with the objective of prevention and early diagnosis of any adverse health effects due to exposure to electromagnetic fields , appropriate health surveillance shall be carried out in&#160 ; accordance with article 14 of directive 89 / 391 / eec . ### with the objective of prevention and early diagnosis of any adverse health effects due to exposure to electromagnetic fields , appropriate health surveillance shall be carried out in&#160 ; accordance with article 14 of directive 89 / 391 / eec . those provisions , including the requirements specified for health records and their availability , shall be introduced with national law and / or practice .


### determination of exposure and assessment of risks ### assessment of risks and determination of exposure


### exposure limit values as well as orientation and action values for both electric and magnetic fields in the frequency range from 0 to 100 khz shall be as set out in annex ii . ### exposure limit values for electromagnetic fields shall be as set out in annex ii .


### a system including exposure limit values , orientation values and action values , wherever applicable , should be seen as a means to facilitate the provision of a high level of protection against the established adverse health effects that may result from exposure to electromagnetic fields . but such a system may conflict with specific conditions in certain activities , such as medical procedures using magnetic resonance techniques or military operations where interoperability is required and where internationally accepted standards providing an equivalent protection of workers subject to specific exposure situations are already in place . it is therefore necessary to take these particular conditions into account . ### a system including exposure limit values and action values , wherever applicable , should be seen as a means to facilitate the provision of a high level of protection against the established adverse health and safety effects that may result from exposure to electromagnetic fields . but such a system may conflict with specific conditions in certain activities , such as specific medical procedures using magnetic resonance techniques or military operations where interoperability is required and where internationally accepted standards providing an equivalent protection of workers subject to specific exposure situations are already in place . it is therefore necessary to take these particular conditions into account .


### take into account the technical progress , changes in the most relevant harmonised european standards or specifications , and new scientific findings concerning electromagnetic fields ; ### take into account the technical progress , changes in the most relevant standards or specifications , and new scientific findings concerning electromagnetic fields ;


### ‘ exposure limit values’ : limits on exposure to electromagnetic fields which have been established on the basis of known health effects and biological considerations . compliance with the exposure limits values for health effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health effects . compliance with the exposure limits values for safety effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health and safety effects ; ### ‘ exposure limit values’ : limits on exposure to electromagnetic fields which have been established on the basis of known health effects and biological considerations , in particular thermal effects and electrical stimulation of tissues ;


### a trading venue that has shares admitted to trading shall establish procedures that ensure that natural or legal persons executing orders on the trading venue mark sell orders as short orders if the seller is entering into a short sale of the share . the trading venue shall publish at least daily a summary of the volume of orders marked as short orders . ### a trading venue that has shares admitted to trading or an investment firm which executes orders on behalf of clients in respect of those instruments outside a trading venue shall establish procedures that ensure that natural or legal persons executing orders on the trading venue or through the investment firm are in a position to mark sell orders as short orders if the seller is entering into a short sale of the share . the trading venue shall publish at least daily a summary of the volume of orders marked as short orders .


### efficient alternatives to phosphates - based household laundry detergents require small amounts of other phosphorous compounds , namely phosphonates which if used in increasing quantities might be of concern for the environment . ### efficient alternatives to phosphates - based household detergents currently require small amounts of other phosphorous compounds , namely phosphonates , or other co - builders such as polycarboxylates . those substances are not readily biodegradable . in its opinion of 29 may 2007 entitled ' non surfactant organic ingredients and zeolite - based detergents ' , the scientific committee on health and environmental risks found that the available information is not sufficient to exclude a potential risk due to those substances and recommended that additional information be provided for a more thorough and complete risk assessment . if those substances were used in increasing quantities as a result of the limitation on the use of phosphates , this might be of concern for the environment .


### by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ” ### by 31 december 2016 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in industrial and institutional detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ”


### by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ### by 31 december 2016 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in industrial and institutional detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications .


### fostering the sustainable development and growth of the fisheries and aquaculture sector , including employment in fisheries and connected sectors ; ### fostering the sustainable development of the fisheries sector and sustainable growth of the aquaculture sector , including employment in fisheries and connected sectors ;


### securing the energy supply of the union by promoting the development of marine energy sources , the development of new and renewable forms of energy , the interconnection of energy networks , and energy efficiency ; ### promoting the development of marine renewable energy sources , their development and the interconnection of energy networks , and energy efficiency ;


### maritime spatial plans and integrated coastal management strategies are subject to the provisions of directive 2001 / 42 / ec . ### maritime spatial plans and integrated coastal management strategies are subject to the provisions of directive 2001 / 42 / ec and of article 6 of directive 92 / 43 / eec where applicable .


### maritime spatial plans and integrated coastal management strategies shall apply an ecosystem - based approach to facilitate the co - existence and prevent conflicts between competing sector activities in marine waters and coastal zones , and shall aim to contribute to : ### maritime spatial plans and integrated coastal management strategies shall apply an ecosystem - based approach to facilitate the co - existence and prevent conflicts between competing sector activities in marine waters and coastal zones . the overarching concern shall be to achieve a healthy eco - system , which is paramount in the development of marine activities . therefore , in the planning process , the precautionary principle shall be applied , where the evidence of environmental impacts is uncertain . member states shall be free to select those of the following areas they wish to develop . maritime spatial plans and integrated coastal management strategies shall aim to contribute to :


### the provisions of this directive shall apply to marine waters and coastal zones . ### the provisions of this directive shall apply to all marine waters and coastal zones of the union .


### ensuring the preservation , protection and improvement of the environment as well as the prudent and rational use of natural resources , notably in order to achieve good environmental status , halt the loss of biodiversity and degradation of ecosystem services and reduce marine pollution risks ; ### ensuring the preservation , protection and improvement of the environment through a representative and coherent network of protected areas , as well as the prudent , precautionary and rational use of natural resources , notably in order to achieve good environmental status , halt the loss of biodiversity and degradation of ecosystem services and to reduce and prevent marine and coastal areas pollution risks ;


### within 30 days of receipt of the report by the pharmacovigilance risk assessment advisory committee , the committee for medicinal products for human use shall consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned . where the opinion states that regulatory action is necessary , the commission shall adopt a decision to vary , suspend or revoke the marketing authorisation . article 10 of this regulation shall apply to the adoption of that decision . where the commission adopts such decision , it may also adopt a decision addressed to the member states pursuant to article 127a of directive 2001 / 83 / ec . ### within 30 days of receipt of the recommendation by the pharmacovigilance risk assessment committee , the committee for medicinal products for human use shall adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned . the chmp shall only adopt an opinion which differs from the recommendation of the pharmacovigilance risk assessment committee , if there exist strong scientific and public health grounds for doing so . the chmp shall explain these grounds in a justification which it shall annex to its opinion . where the opinion states that regulatory action is necessary , the commission shall adopt a decision to vary , suspend or revoke the marketing authorisation . article 10 of this regulation shall apply to the adoption of that decision . where the commission adopts such decision , it may also adopt a decision addressed to the member states pursuant to article 127a of directive 2001 / 83 / ec .


### a summary of each meeting of the committees referred to in points and of article 56 of this regulation and the coordination group as regards pharmacovigilance activities ; ### agendas for meetings and records of meetings , accompanied by decisions taken , details of votes and explanations of votes , including minority opinions , of the committees referred to in points and of article 56 of this regulation and the coordination group as regards pharmacovigilance activities ;


### the main tasks of the agency in the area of pharmacovigilance laid down in regulation no 726 / 2004 should be maintained and further developed , in particular as regards the management of the community pharmacovigilance database and data - processing network and the coordination of safety announcements by the member states . ### the main tasks of the agency in the area of pharmacovigilance laid down in regulation no 726 / 2004 should be maintained and further developed , in particular as regards the management of the community pharmacovigilance database and data - processing network , the coordination of safety announcements by the member states and the provision of information regarding safety issues to the public .


### upon request of the commission , the agency shall participate in collaboration with the member states in international harmonization and standardization of technical measures in pharmacovigilance . ### at the commission ' s request , the agency shall participate , in collaboration with the member states and all interested parties , in international harmonisation and standardisation of technical measures in pharmacovigilance . such work shall be based on patient needs and be carried out from a scientific perspective .


### the pharmacovigilance risk assessment advisory committee , which shall be responsible for providing advice to the committee for medicinal products for human use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human use ; ### the pharmacovigilance committee , which shall be responsible for the pharmacovigilance assessment , after marketing authorisation has been granted , of medicinal products placed on the market in accordance with the centralised procedure ;


### for the fulfilment of its pharmacovigilance tasks , it shall be assisted by the pharmacovigilance risk assessment advisory committee referred to in article 56 . ### for the fulfilment of its pharmacovigilance tasks , it shall be assisted by the pharmacovigilance committee referred to in article 56 .


### within 30 days of receipt of the report by the pharmacovigilance risk assessment advisory committee , the committee for medicinal products for human use shall consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned . ### within 30 days of adoption of the report , the pharmacovigilance committee shall adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned .


### the agency , in collaboration with the member states , shall develop standard web - based structured forms for the reporting of suspected adverse reactions by health - care professionals and patients . ### the agency , in collaboration with the member states and relevant stakeholders , shall develop standard content , formats and procedures for the reporting of suspected adverse reactions by health - care professionals and patients and the traceability of biological medicinal products prescribed , dispensed , or sold on eu territory . forms intended for patients must be designed according to technical criteria conforming to the principles of clear structure and simplified language accessible to the general public . they must be accessible on the internet and in pharmacies . the forms must include the information required to enable reports to be submitted to the authorities by pharmacies or directly by patients , by post , by fax , or electronically .


### - factual , informative announcements and reference material relating , for example , to pack changes , adverse - reaction warnings as part of general drug precautions , trade catalogues and price lists , provided they include no product claims ; ### - factual , informative announcements and reference material relating , for example , to availability , pack changes , adverse - reaction warnings as part of general drug precautions , trade catalogues and price lists , information on the environmental risk of the medicinal product and information relating to the disposal of unused medicinal product or waste derived from medicinal products as well as reference to any collection system in place , provided they include no product claims and they do not induce to or promote the consumption of the medicinal product ;


### the following types of information on authorised medicinal products subject to medical prescription may be disseminated by the marketing authorisation holder to the general public or members thereof : ### the following documents on authorised medicinal products subject to medical prescription may be made available by the marketing authorisation holder to the general public or members thereof .


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only make available material which is in compliance with title viiia of directive 2001 / 83 / ec . member states should adopt rules establishing effective independent monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities .


### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information . ### in order to further ensure that marketing authorisation holders disseminate only validated statutory information , it is appropriate to allow marketing authorisation holders to make available the approved summaries of product characteristics and the approved package leaflet .


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### member states shall allow the marketing authorisation holder , either directly or indirectly through a third party , to make available on their website official documents on authorised medicinal products subject to medical prescription in the official languages of the member states where they are authorised . member states shall also allow the marketing authorisation holder to make available on their websites information on authorised medicinal products subject to medical prescription as listed in article 86 . when such information is made available , the marketing authorisation holder and any third party acting on behalf of the marketing authorisation holder shall be clearly identified .


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only make available material which is in compliance with title viiia of directive 2001 / 83 / ec . member states should adopt rules establishing effective independent monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination .


### information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio . it shall only be made available through the following channels : health - related publications as defined by the member state of publication , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; b ) internet websites on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; c ) written answers to requests for information of a member of the general public . ### documents on authorised medicinal products subject to medical prescription shall only be made available by the marketing authorisation holder to the general public via their website .


### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website . ### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website . the marketing authorisation holder shall remain fully responsible and liable for all the information it disseminates to the general public .


### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website . ### the marketing authorisation holder shall send the new contents and changes referred to in paragraph 1 to the competent authorities of the member state where the internet website has been registered for prior approval , before making available the new contents or changes on its website . the marketing authorisation holder shall remain fully responsible and liable for all the information it disseminates to the general public .


### supply the authorities or bodies responsible for monitoring information on medicinal products with the information and assistance they require to carry out their responsibilities ; ### supply the authorities or bodies responsible for monitoring information on medicinal products with the information , the financial resources and assistance they require to carry out their responsibilities ;


### information on homeopathic medicinal products referred to in article 14 that have been classified as prescription - only shall be subject to the provisions of this title . ### information on homeopathic and herbal medicinal products referred to in article 14 that have been classified as prescription - only shall be subject to the provisions of this title .


### the reassessment of infrastructure investment programmes by member states in the context of their fiscal austerity and structural reforms will not facilitate the required acceleration of the pace of infrastructure investment . in addition , long - term bank lending for infrastructure projects continues to be insufficient and expensive , calling for alternative and competitive sources of debt financing . ### the reassessment of infrastructure investment programmes by member states in the context of their fiscal austerity and structural reforms will not facilitate the required acceleration of the pace of infrastructure investment needed to meet the policy objectives of the europe 2020 strategy , in particular a shift towards a resource - efficient , low - carbon economy to achieve sustainable growth , as laid down in the europe 2020 resource efficiency flagship initiative . in addition , long - term bank lending for infrastructure projects continues to be insufficient and expensive , calling for alternative and competitive sources of debt financing .


### in order to implement the pilot phase of the europe 2020 project bond initiative , decision no 1639 / 2006 / ec and regulation no 680 / 2007 should be amended . this pilot phase aims to support infrastructure projects with commercial potential in the transport , energy and ict sectors , while after 2013 the initiative may be extended to other sectors . ### in order to implement the pilot phase of the europe 2020 project bond initiative , decision no 1639 / 2006 / ec and regulation no 680 / 2007 should be amended . this pilot phase aims to support infrastructure projects with commercial potential and socio - economic benefits in line with the europe 2020 strategy , in particular the resource efficiency flagship initiative , in the transport , energy and ict sectors , while after 2013 the initiative should be extended to other sectors , in particular to renewable energy and building renovation .


### ‘ from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 096 . ’ ### ' from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 096 . '


### the passenger information unit of a member state shall have the right to request , if necessary , the passenger information unit of any other member state to provide it with pnr data that are kept in the latter ' s database in accordance with article 9 , and , if necessary , also the result of the processing of pnr data . the passenger information unit may request access to specific pnr data kept by the passenger information unit of another member state in their full form without the masking out only in exceptional circumstances in response to a specific threat or a specific investigation or prosecution related to terrorist offences or serious crime . ### the passenger information unit of a member state shall have the right to request , if necessary , the passenger information unit of any other member state to provide it with pnr data that are kept in the latter ' s database in accordance with article 9 , and , if necessary , also the result of the processing of pnr data . the passenger information unit may request access to specific pnr data kept by the passenger information unit of another member state in their full form without the masking out only in exceptional circumstances in response to a specific threat or a specific investigation or prosecution related to terrorist offences or serious transnational crime . such a request shall be justified in writing .


### ' serious transnational crime ' means the offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha if they are punishable by a custodial sentence or a detention order for a maximum period of at least three years under the national law of a member state , and if : ### ' serious transnational crime ' means the following offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha : trafficking in human beings , illicit trafficking in narcotic drugs and illicit trafficking in weapons , munitions and explosives , if they are punishable by a custodial sentence or a detention order for a maximum period of at least three years under the national law of a member state , and if :


### after analysing the information obtained , require any such person to take steps to reduce the size of the position or exposure ; ### after analysing the information obtained , require any such person or class of investors to take steps to reduce the size of the position or exposure ;


### the measures listed in points to of paragraph 1 address a threat to the orderly functioning and integrity of financial markets including in relation to delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union ; ### the measures listed in points to of paragraph 1 address a threat to the efficient and orderly functioning and integrity of financial markets including in relation to delivery arrangements for physical commodities , consisting in excessive speculation and market manipulation , increased volatility or distortion of price discovery , or a threat to the stability of the whole or part of the financial system in the union or a distortion of risk management functions of commodity markets ;


### does significantly address the threat to the orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union or significantly improve the ability of competent authorities to monitor the threat ; ### addresses the threat to the efficient and orderly functioning and integrity of financial markets or of delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union or improve the ability of competent authorities to monitor the threat ;


### the commission shall adopt by means of delegated acts in accordance with article 41 measures specifying criteria and factors to be taken into account by esma in determining when a threat to the orderly functioning and integrity of financial markets including in relation to delivery arrangements for physical commodities , or the stability of the whole or part of the financial system in the union referred to in paragraph 2 arise . ### esma shall develop drafts for regulatory technical standards specifying the measures , criteria and factors that it shall take into account in determining whether the circumstances referred to in paragraph 2 arise .


### does not have a detrimental effect on the efficiency of financial markets , including reducing liquidity in those markets or creating uncertainty for market participants , that is disproportionate to the benefits of the measure . ### does not have a detrimental effect on the efficiency of financial markets , including reducing liquidity required by bona fide hedging transactions in those markets or creating uncertainty for market participants , that is disproportionate to the benefits of the measure .


### esma powers to temporarily intervene ### esma intervention powers


### esma shall only take a decision under paragraph 1 if all of the following conditions are fulfilled : ### without prejudice to the measures foreseen in article 59 of directive new mifid , esma shall only take a decision under paragraph 1 if one or more of the following conditions are fulfilled :


### the reports shall , in particular , include details of the names and numbers of the instruments bought or sold , the quantity , the dates and times of execution , the transaction prices , a designation to identify the clients on whose behalf the investment firm has executed that transaction , a designation to identify the persons and the computer algorithms within the investment firm responsible for the investment decision and the execution of the transaction , and means of identifying the investment firms concerned . for transactions not carried out on a regulated market , mtf or otf , the reports shall also include a designation identifying the types of transactions in accordance with the measures to be adopted pursuant to article 19 and article 20 . ### the reports shall , in particular , include details of the type , the class of assets , the names and numbers of the instruments bought or sold , the quantity , the dates and times of execution , the transaction prices , a designation to identify the clients on whose behalf the investment firm has executed that transaction , a designation to identify the persons and the computer algorithms within the investment firm responsible for the investment decision and the execution of the transaction , and means of identifying the investment firms concerned . additionally , for transactions related to commodity derivatives , the report shall indicate whether such transactions qualify as bona - fide hedging transactions . for transactions not carried out on a regulated market , mtf or otf , the reports shall also include a designation identifying the types of transactions in accordance with the measures to be adopted pursuant to article 19 and article 20 .


### limit the ability of a person from entering into a commodity derivative . ### limit the ability of a person from entering into a commodity derivative or prohibit new classes of contracts .


### concern infrastructure related to the development and adaptation of agriculture , including access to farm and forest land , land consolidation and improvement , energy supply and , water management ; or ### concern environmentally friendly infrastructure related to the development and adaptation of agriculture , including access to farm and forest land , land consolidation and improvement , energy supply and , water management , in accordance with priorities 4 and 5 ; or


### a eip network shall be put in place to support the eip for agricultural productivity and sustainability referred to in article 61 , in accordance with article 51 . it shall enable the networking of operational groups , advisory services and researchers ### a eip network shall be put in place to support the eip for agricultural productivity and sustainability referred to in article 61 , in accordance with article 51 . it shall enable the networking of operational groups , advisory services , non - governmental organisations and researchers .


### commitments under this measure shall be undertaken for a period of five to seven years . where support is granted for the maintenance of organic farming , member states may provide in their rural development programmes for annual extension after the termination of the initial period . ### commitments under this measure shall be undertaken for a period of five to seven years . member states shall establish a mechanism to incentivise farmers in taking part in the follow - up measure after 2020 in order to encourage the uptake of this measure also after 2015 . where support is granted for the maintenance of organic farming , member states may provide in their rural development programmes for annual extension after the termination of the initial period .


### facilitating the supply and use of renewable sources of energy , of by - products , wastes , residues and other non food raw material for purposes of the bio - economy ; ### facilitating the local supply and use of renewable sources of energy , of by - products , wastes , residues and other non food raw material for purposes of the bio - economy ;


### protecting and restoring biodiversity , including through green infrastructures ; ### protecting and restoring biodiversity , including through green infrastructures and management of natura 2000 sites ;


### the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food , in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance ; in such cases the indication shall be in accordance with the rules laid down in article 35 and and those established in accordance with article 35 ; ### the country of origin or place of provenance shall be indicated using the following specifications : in the case of non - composite foodstuffs , the region of provenance ; in the case of composite foodstuffs , the country of provenance of the primary ingredient and , if possible , the region of provenance ; in the case of meat , other than beef and veal , the country of origin or place of provenance may be given as a single place only where animals have been born , reared and slaughtered in the same country or place . in all other cases information on each of the different places of birth , rearing and slaughter shall be given .


### the amounts of fat , saturates , carbohydrates with specific reference to sugars , and salt . ### the amounts of fat , saturates , industrial transfatty acids and carbohydrates with specific reference to natural and added sugars , and salt .


### that clearing obligation shall also apply to financial counterparties and to the non - financial counterparties referred to in article 7 which enter into eligible otc derivative contracts with third country entities . ### that clearing obligation shall also apply to financial counterparties and to the non - financial counterparties referred to in article 7 which enter into eligible derivative contracts with third country entities .


### where a non - financial counterparty takes positions in otc derivative contracts exceeding the clearing threshold to be determined pursuant to paragraph 3 , it shall be subject to the clearing obligation set out in article 3 with regard to all its eligible otc derivative contracts . ### where a non - financial counterparty takes positions in derivative contracts , which , at the time the position is taken , exceed the clearing threshold to be determined pursuant to paragraph 3 , it shall be subject to the clearing obligation set out in article 3 with regard to all its eligible derivative contracts .


### where possible , electronic means ensuring the timely confirmation of the terms of the otc derivative contract ; ### electronic means ensuring the timely confirmation of the terms of the otc derivative contract ;


### esma shall develop draft regulatory technical standards for submission to the commission by 30 june 2012 . ### esma shall develop draft regulatory technical standards for submission to the commission by 30 june 2012 . where the draft regulatory technical standards concern wholesale energy products within the meaning of the regulation on energy market integrity and transparency 726 / 3 ) esma shall consult the agency for the cooperation of energy regulators .


### a financial counterparty shall clear all otc derivative contracts which are considered eligible pursuant to article 4 and are concluded with other financial counterparties in the relevant ccps listed in the register as referred to in article 4 . ### a financial counterparty and a non financial counterparty as referred to in article 7 shall clear all otc derivative contracts which are considered eligible pursuant to article 4 and are concluded with other financial counterparties and a non financial counterparty as referred to in article 7 in the relevant ccps listed in the register as referred to in article 4 .


### where a non - financial counterparty takes positions in otc derivative contracts exceeding the clearing threshold to be determined pursuant to paragraph 3 , it shall be subject to the clearing obligation set out in article 3 with regard to all its eligible otc derivative contracts . ### where a non - financial counterparty takes positions in derivative contracts such that the average position over 90 days exceeds the threshold to be determined pursuant to paragraph 3 , it shall be subject to the clearing obligation set out in article 3 with regard to all its eligible derivative contracts .


### competent authorities 2 . each member state shall ensure that the competent authorities have the supervisory and investigatory powers necessary for the exercise of their functions . ### competent authorities 2 . each member state shall ensure that esma have supervisory and investigatory powers necessary for the exercise of their functions .


### financial counterparties or the non - financial counterparties referred to in article 7 , that enter into an otc derivative contract not cleared by a ccp , shall ensure that appropriate procedures and arrangements are in place to measure , monitor and mitigate operational and credit risk , including at least : ### financial counterparties or the non - financial counterparties referred to in article 7 , that enter into a derivative contract not cleared by a ccp , shall ensure with due diligence that appropriate prudential procedures and arrangements are in place to measure , monitor and mitigate operational , market and credit risk , including at least :


### late payment is particularly regrettable if it occurs despite the debtor’s solvency . surveys show that public authorities often pay invoices very late after expiration of the applicable payment period . public authorities may face lighter financing constraints because they may benefit from more secure , predictable and continuous revenue streams than private undertakings . at the same time , they depend less than private undertakings on the building stable commercial relationships for the achievement of their aims . consequently , public authorities can obtain financing at more attractive conditions than private undertakings . therefore , late payment by public authorities not only leads to unjustified costs for private undertakings , but to inefficiency in general . it is therefore appropriate to introduce correspondingly higher dissuasive compensation in case of late payment by public authorities . ### late payment is particularly regrettable if it occurs despite the debtor’s solvency , regardless of whether the debtor is from the public or the private sector . therefore penalties and other measures intended to dissuade late payment should as a general rule apply equally to both sectors .


### if the date or period for payment is not fixed in the contract , interest for late payment shall become payable automatically within any of the following time limits : 30 days following the date of receipt by the debtor of the invoice or an equivalent request for payment ; if the debtor receives the invoice or the equivalent request for payment earlier than the goods or the services , 30 days after the receipt of the goods or services ; if a procedure of acceptance or verification , by which the conformity of the goods or services with the contract is to be ascertained , is provided for by statute or in the contract and if the debtor receives the invoice or the equivalent request for payment earlier or on the date on which such acceptance or verification takes place , 30 days after that date . ### if the date for payment is not fixed in the contract , interest for late payment shall become payable automatically within any of the following time limits : 30 days following the date of receipt by the debtor of the checkable invoice or an equivalent request for payment ; if the debtor receives the checkable invoice or the equivalent request for payment earlier than the goods or the services , 30 days after the receipt of the goods or services ; if a procedure of acceptance or verification , by which the conformity of the goods or services with the contract is to be ascertained , is provided for by statute or in the contract and if the debtor receives the checkable invoice or the equivalent request for payment earlier or on the date on which such acceptance or verification takes place , 30 days after that date .


### ‘ statutory interest’ means simple interest for late payment at a rate which is the sum of the reference rate , plus at least seven percentage points ; ### ‘ statutory interest’ means simple interest for late payment at a rate which is the sum of the reference rate , plus at least nine percentage points ;


### if the date or period for payment is not fixed in the contract , interest for late payment shall become payable automatically within any of the following time limits : 30 days following the date of receipt by the debtor of the invoice or an equivalent request for payment ; if the debtor receives the invoice or the equivalent request for payment earlier than the goods or the services , 30 days after the receipt of the goods or services ; if a procedure of acceptance or verification , by which the conformity of the goods or services with the contract is to be ascertained , is provided for by statute or in the contract and if the debtor receives the invoice or the equivalent request for payment earlier or on the date on which such acceptance or verification takes place , 30 days after that date . ### if the date for payment is not fixed in the contract , interest for late payment shall become payable automatically within any of the following time limits : up to 60 calendar days following the due date and the date of receipt by the debtor of the checkable invoice or an equivalent request for payment ; if the debtor receives the checkable invoice or the equivalent request for payment earlier than the goods or the services , up to 60 calendar days after the receipt of the goods or services ; if a procedure of acceptance or verification , by which the conformity of the goods or services with the contract is to be ascertained , is provided for by statute or in the contract and if the debtor receives the checkable invoice or the equivalent request for payment earlier or on the date on which such acceptance or verification takes place , up to 60 calendar days after that date .


### that air carrier can demonstrate to the satisfaction of the coordinator that the series of slots in question has been operated , as cleared by the coordinator , by that air carrier for at least 85 % of the time during the scheduling period for which it has been allocated . ### that air carrier can demonstrate to the satisfaction of the coordinator that the series of slots in question has been operated , as cleared by the coordinator , by that air carrier for at least 80 % of the time during the scheduling period for which it has been allocated .


### if the 85 % usage of the series of slots cannot be demonstrated , the priority provided under paragraph shall not be given , unless the non - utilisation can be justified on the basis of any of the following reasons : ### if the 80 % usage of the series of slots cannot be demonstrated , the priority provided under paragraph shall not be given , unless the non - utilisation can be justified on the basis of any of the following reasons :


### protecting the environment and promoting resource efficiency : ### protecting the environment , biodiversity and ecosystems , and promoting resource efficiency :


### at least 80% of the total erdf resources at national level shall be allocated to the thematic objectives set out in points 1 , 3 and 4 of article 9 of regulation no [ &#8230 ; ] / 2012 [ cpr ] ; ### at least 80% of the total erdf resources at national level shall be allocated to the thematic objectives set out in points 1 , 3 , 4 and 6 of article 9 of regulation no [ &#8230 ; ] / 2012 [ cpr ] ;


### at least 20% of the total erdf resources at national level shall be allocated to the thematic objective set out in point 4 of article 9 of regulation no [ … ] / 2012 [ cpr ] ; ### at least 40% of the total erdf resources at national level shall be allocated to the thematic objective set out in point 4 of article 9 of regulation no [ … ] / 2012 [ cpr ] , where investments under this objective outside the transport sector shall represent at least 30% of the total erdf resources at national level ;


### all statements of support shall be collected after the date of registration of the proposed initiative and within a period that shall not exceed 12 months . ### all statements of support shall be collected after the date of registration of the proposed initiative and within a period that shall not exceed 24 months .


### it is appropriate to fix a minimum age for supporting a citizens ' initiative . this should be set as the age at which citizens are entitled to vote in the european parliament elections . ### it is appropriate to fix a minimum age for supporting a citizens ' initiative . this should be set at 16 years of age .


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . ### the organising committee shall be comprised of members who are citizens of the union old enough to be entitled to vote in the european elections , who are not currently serving as directly elected politicians .


### “organiser” means a natural or legal person or organisation responsible for the preparation and submission of a citizens’ initiative to the commission . ### “organising committee” means a group of at least seven citizens or residents of the union , coming from three or more member states , responsible for the preparation and submission of a citizens’ initiative to the commission .


### the commission shall reject the registration of proposed citizens ' initiatives which are manifestly against the values of the union . ### the commission shall reject the registration of proposed citizens’ initiatives which are manifestly against the values of the union , taking this decision on the basis of a clear legal examination . a citizens ' initiative should be rejected when it is in contradiction with article 6 of the treaty on european union , the charter of fundamental rights of the european union , or the european convention for the protection of human rights and fundamental freedoms .


### the commission shall seek information and views regarding the union ' s economic interests in specific products or sectors , in the application of this regulation , through a notice in the official journal of the european union or other suitable public communication means . ### the commission shall seek information and views regarding the union ' s economic interests in specific products or sectors , in the application of this regulation , through a notice in the official journal of the european union setting the modalities for submitting information and the deadlines by which submissions are to be made .


### in the absence of horizontal community legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursue a further development of a coherent immigration policy , to lower the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member states but not yet long term residents . such provisions are intended to establish a level playing field within the eu , to recognize that such third - country nationals legally working in a member states contribute to the european economy through their work and tax payments and to serve as safeguard to reduce unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter . ### in the absence of horizontal community legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursue a further development of a coherent immigration policy , to lower the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member state but not yet long term residents . such provisions are intended to establish a level playing field within the eu , to recognize third - country national’s contribution to the european society and to fight against unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter .


### branches of social security , as defined in council regulation no 1408 / 71 of 14 june 1971 on the application of social security schemes to employed persons , to self - employed persons and to members of their families moving within the community . regulation no 859 / 2003 , extending the provisions of regulation no 1408 / 71 and its implementing regulation no 574 / 72 to nationals of third countries who are not already covered by these provisions solely on the ground of their nationality shall apply accordingly ; ### provisions in national law concerning branches of social security , as defined in regulation no 883 / 2004 of the european parliament and of the council of 29 april 2004 on the coordination of social security systems . regulation no 859 / 2003 , extending the provisions of regulation no 1408 / 71 and its implementing regulation no 574 / 72 to nationals of third countries who are not already covered by these provisions solely on the ground of their nationality shall apply accordingly ;


### third - country nationals who work in the territory of a member state should enjoy equal treatment as regards social security . branches of social security are defined in the council regulation no 1408 / 71 of 14 june 1971 on the application of social security schemes to employed persons , to self - employed persons and to members of their families moving within the community . council regulation no 859 / 2003 of 14 may 2003 extending the provisions of regulation no 1408 / 71 and regulation no 574 / 72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality extends the provisions of regulation no 1408 / 71 to third country nationals who are legally residing in the european union and who are in a cross - border situation . the provisions on equal treatment concerning social security in this directive also apply to persons coming to a member state directly from a third country . nevertheless , this directive should not confer more rights than those already provided in existing community legislation in the field of social security for third - country nationals who have cross - border elements between member states . ### third - country nationals who work in the territory of a member state should enjoy equal treatment as regards social security . branches of social security are defined in regulation no 883 / 2004 of the european parliament and of the council of 29 april 2004 on the coordination of social security systems . council regulation no 859 / 2003 of 14 may 2003 extending the provisions of regulation no 1408 / 71 and regulation no 574 / 72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality extends the provisions of regulation no 1408 / 71 to third country nationals who are legally residing in the european union and who are in a situation subject to the law of more than one member state . the provisions on equal treatment concerning social security in this proposal also apply directly to persons entering a member state directly from a third country , provided that they reside legally in that member state and that they meet the conditions of eligibility for the social security benefits in question that are laid down under national law . nevertheless , this directive should not confer more rights than those currently conferred in existing community legislation in the field of social security for third - country nationals who have cross - border elements between member states . nor should it confer rights in respect of situations that do not fall within the scope of eu legislation , as , for example , in the case of family members resident in a third country .


### third - country nationals who work in the territory of a member state should enjoy equal treatment as regards social security . branches of social security are defined in the council regulation no 1408 / 71 of 14 june 1971 on the application of social security schemes to employed persons , to self - employed persons and to members of their families moving within the community . council regulation no 859 / 2003 of 14 may 2003 extending the provisions of regulation no 1408 / 71 and regulation no 574 / 72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality extends the provisions of regulation no 1408 / 71 to third country nationals who are legally residing in the european union and who are in a cross - border situation . the provisions on equal treatment concerning social security in this directive also apply to persons coming to a member state directly from a third country . nevertheless , this directive should not confer more rights than those already provided in existing community legislation in the field of social security for third - country nationals who have cross - border elements between member states . ### third - country nationals who work in the territory of a member state should enjoy equal treatment as regards social security . branches of social security are defined in regulation no 883 / 2004 of the european parliament and of the council of 29 april 2004 on the coordination of social security systems . council regulation no 859 / 2003 of 14 may 2003 extending the provisions of regulation no 1408 / 71 and regulation no 574 / 72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality extends the provisions of regulation no 1408 / 71 to third country nationals who are legally residing in the european union and who are in a cross - border situation . the provisions on equal treatment concerning social security in this directive also apply to persons coming to a member state directly from a third country .


### working conditions , including pay and dismissal as well as health and safety at the workplace ; ### working conditions , including pay , leave , working time and dismissal as well as health and safety at the workplace , taking into account general collective agreements in force ;


### in the absence of horizontal community legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursue a further development of a coherent immigration policy , to lower the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member states but not yet long term residents . such provisions are intended to establish a level playing field within the eu , to recognize that such third - country nationals legally working in a member states contribute to the european economy through their work and tax payments and to serve as a safeguard to reduce unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter . ### in the absence of horizontal community legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursue a further development of a coherent immigration policy , to lower the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member states but not yet long term residents . such provisions are intended to establish a level playing field within the eu , to recognize third - country national’s contribution to the european society and to fight against unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter .


### working conditions , including pay and dismissal as well as health and safety at the workplace ; ### working conditions , including pay , leave , working time and dismissal as well as health and safety at the workplace ;


### in the absence of horizontal community legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursue a further development of a coherent immigration policy , to lower the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member states but not yet long term residents . such provisions are intended to establish a level playing field within the eu , to recognize that such third - country nationals legally working in a member states contribute to the european economy through their work and tax payments and to serve as a safeguard to reduce unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter . ### in the absence of horizontal eu legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursuing further development of a coherent immigration policy , narrowing the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of socio - economic and labour - law rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member state but not yet long - term residents . such provisions are intended to introduce a minimum level of fairness within the eu , to recognise that such third - country nationals legally working in member states contribute to the european economy through their work and tax payments and to serve as a safeguard to reduce unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter .


### in article 36 , the following paragraph 2a is inserted : ' 2a . member states meeting one of the conditions set out in article 77 , may contribute a part of the financial allocations indicated in article 19 and article 20 to a risk sharing instrument , to be established by the commission in agreement with the european investment bank , or in agreement with national or international public sector bodies or bodies governed by private law with a public service mission providing adequate guarantees as referred to in article 54 of regulation no 1605 / 2002 , under similar terms and conditions to those applied to and by the european investment bank , to cover the provisioning and capital allocation of guarantees and loans , as well as other financial facilities , granted under the risk sharing instrument . such risk sharing instrument shall be used exclusively for loans and guarantees , as well as other financial facilities , to finance operations co - financed by the european regional development fund or the cohesion fund , regarding expenditure which is not covered by article 56 . the risk sharing instrument shall be implemented by the commission within the framework of indirect centralised management in accordance with article 54 of regulation no 1605 / 2002 . payments to the risk sharing instrument shall be made in tranches , in accordance with the scheduled use of the risk sharing instrument in providing loans and guarantees financing specific operations . the member state concerned shall address a request to the commission who shall adopt a decision by means of an implementing act , describing the system established to guarantee that the amount available is used for the exclusive benefit of the member state which provided it within its cohesion policy financial allocation pursuant to article 18 , as well as the terms and conditions applicable to such risk sharing instrument . these terms and conditions shall at least address the following : traceability and accounting , information on the use of the funds and monitoring and control systems ; and structure of the fees and other administrative and management costs . the financial allocations to the risk - sharing instrument shall be strictly capped and shall not create contingent liabilities for the union budget or the member state concerned . any amount left - over after the completion of an operation covered by the risk sharing instrument may be reused , at the request of the member sate concerned , within the risk - sharing instrument , if the member state still meets one of the conditions set out as specified in article 77 . if the member state no longer meets those conditions , the amount left - over shall be considered as assigned revenue within the meaning of article 18 of the financial regulation . at the request of the member state concerned , additional commitment appropriations generated by this assigned revenue shall be added the following year to the cohesion policy financial allocation of the member state concerned . ' ### the following article is inserted : ' article 36a risk sharing instrument for the purpose of this article a risk - sharing instrument means a financial instrument which guarantees the total or partial coverage of a defined risk , where appropriate in exchange for an agreed remuneration . 2 . member states meeting one of the conditions set out in article 77a , b and c , may contribute a part of the financial allocations indicated in article 19 and article 20 to a risk sharing instrument , which shall be established by means of a cooperation agreement , to be concluded by the commission either with the european investment bank , or with national or international public sector bodies or bodies governed by private law with a public service mission providing adequate guarantees as referred to in article 54 of regulation no 1605 / 2002 , under similar terms and conditions to those applied to and by the european investment bank , to cover the provisioning and capital allocation of guarantees and loans , as well as other financial facilities , granted under the risk sharing instrument . 3 . the cooperation agreement , referred to in paragraph 2 , shall contain rules in particular on the following : the total amount of the union contribution and the schedule about how it will be made available ; the trust account conditions to be set up by the contracted implementing body ; the eligibility criteria for the use of the union contribution , the details of the exact risk - sharing , to be ensured and the guarantees to be provided by the contracted implementing body ; the pricing of instrument , based on the risk margin and the coverage of all the administrative costs of the instrument ; the application and approval procedure of the project proposals , covered by the instrument ; the period of availability of the instrument and the reporting requirements . the exact risk - sharing , which shall be undertaken in the cooperation agreement by the contracted implementing body , shall as an average aim at being at least 1 , 5 times the amount of the union contribution to the risk - sharing instrument . payments to the risk sharing instrument shall be made in tranches , in accordance with the scheduled use of the risk sharing instrument in providing loans and guarantees financing specific operations . 4 . the risk sharing instrument shall be used to finance operations co - financed by the european regional development fund or the cohesion fund , regarding , by way of derogation from article 54 , investment costs which cannot be taken into account as eligible expenditure pursuant to article 55 or as public expenditure as defined in article 2 , pursuant to the eu rules on state aids . it may also be used to finance operations , which contribute to the achievement of the objectives of the national strategic reference framework of the requesting member state and the community strategic guidelines on cohesion1 , and bring the greatest added value to the union strategy for smart , sustainable and inclusive growth . 5 . the risk sharing instrument shall be implemented by the commission within the framework of indirect centralised management in accordance with article 54 and article 56 of regulation no 1605 / 2002 . 6 . an eligible member state seeking to benefit from a risk - sharing instrument shall submit a written request to the commission not later than 31 august 2013 . in its request , the member state shall provide all the information necessary to establish : that it meets one of the conditions referred to in points , or of article 77 , by providing a reference to a council decision or other legal act proving this fact ; the list of programmes co - financed either by the erdf or by the cf and the part of the 2012 and 2013 allocations to such programmes that it wants to take out of those programmes in order to reallocate those amounts to the risk - sharing instrument ; the list of proposed projects pursuant to paragraph 4 and the part of the 2012 and 2013 allocations that it wants to take out of the programmes in order to reallocate those amounts to the risk - sharing instrument ; the amount available for its exclusive benefit within its cohesion policy financial allocation pursuant to article 18 and an indication on the amount , which could be earmarked for the objectives of the risk - sharing instrument exclusively from the eu budget commitments which remain to be effected in years 2012 and 2013 pursuant to article 75 ; 7 . the commission - after verifying that the member state request is justified - shall adopt within four months a decision describing the system established to guarantee that the amount available is used for the exclusive benefit of the member state which provided it within its cohesion policy financial allocation pursuant to article 18 , as well as on the concrete terms and conditions of the participation of the requesting member state in the risk sharing instrument . the concrete terms and conditions shall in particular address the following : traceability and accounting , information on the use of the funds , payments conditions and monitoring and control systems ; structure of the fees and other administrative and management costs ; indicative list of eligible projects for financing and the maximum amount of the union contribution that can be allocated to the risk - sharing instrument from the member state allocations available , and the instalments for practical implementation . the commission decision shall be published in the official journal of the european union . when deciding on the member state request , the commission shall ensure that only projects , for which a favourable financing decision has been taken either by the eib or by a national or international public sector body or body governed by private law with a public service mission , shall be accepted as eligible from being financed from an established risk - sharing instrument . 8 . the commission decision , referred to in paragraph shall be preceded by the revision of the operational programmes concerned under the erdf and cf in accordance with article 33 . 9 . the financial allocations to the risk - sharing instrument shall be strictly capped and shall not exceed 10% of the indicative total allocation for the requesting member state for the years 2007 - 2013 regarding erdf and cf , which was approved in accordance with article 28b . the financial allocations available to the projects in paragraph 4 , subparagraph 2 of this article are limited to the amounts left after financing the operations mentioned in paragraph 4 , subparagraph 1 . beyond the total union contribution to the risk - sharing instrument , endorsed in the decision , referred to in paragraph , the union participation in a risk - sharing instrument shall not create any further contingent liabilities neither for the union budget nor for the member state concerned . 10 . any amount left - over after the completion of an operation covered by the risk sharing instrument may be reused , at the request of the member state concerned , within the risk - sharing instrument , if the member state still meets one of the conditions set out in article 77a , b and c . if the member state no longer meets any of those conditions , the amount left - over shall be considered as assigned revenue within the meaning of article 18 of the financial regulation . at the request of the member state concerned , additional commitment appropriations generated by this assigned revenue shall be added the following year to the cohesion policy financial allocation of the member state concerned . _______________ 1 see : council decision no . 2006 / 702 / ec of 6 october 2006 on community strategic guidelines on cohesion , oj l 291 , 21 . 10 . 2006 , p . 11 . 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