### every step in the clinical investigation , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects , adopted by the 18th world medical association general assembly in helsinki , finland , in 1964 , and last amended by the 59th world medical association general assembly in seoul , korea , in 2008 . ### every step in the clinical investigation , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects , adopted by the 18th world medical association general assembly in helsinki , finland , in 1964 , and any subsequent amendments .


### following the review , certain provisions of the regulations should be amended in order to improve transparency and predictability , provide for effective measures to fight against retaliation , improve effectiveness and enforcement and optimise review practice . in addition , certain practices that in recent years have been applied in the context of anti - dumping and anti - subsidy investigations should be included in the regulations . ### following the review , certain provisions of the regulations should be amended in order to improve transparency and predictability , provide for effective measures to fight against retaliation by third countries , improve effectiveness and enforcement and optimise review practice . in addition , certain practices that in recent years have been applied in the context of anti - dumping and anti - subsidy investigations should be included in the regulations .


### when an investigation is not initiated by a complaint , an obligation should be imposed on union producers to provide the necessary information in order for the investigation to proceed , in order to ensure that sufficient information is available for carrying out the investigation in case of such threats of retaliation . ### when an investigation is not initiated by a complaint , a request for cooperation should be made to union producers to provide the necessary information in order for the investigation to proceed , in order to ensure that sufficient information is available for carrying out the investigation in case of such threats of retaliation .


### if in special circumstances , it is decided to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation . ### article 5 , paragraph 6 shall be replaced by the following : 6 . if in duly justified circumstances , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , the commission shall conduct this investigation on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation .


### if in special circumstances , it is decided to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation . ### article 5 shall be replaced by the following : 6 . if , in special circumstances , such as in the case of diverse and fragmented industry sectors , largely composed of small - and medium - sized enterprises , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation .


### if , in special circumstances , the commission decides to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of the existence of countervailable subsidies , injury and causal link , as described in paragraph 2 , to justify such initiation . ### article 10 shall be replaced by the following : 8 . if in duly justified circumstances , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , the commission shall conduct this investigation on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation .


### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established .


### the amount of the anti - dumping duty shall not exceed the margin of dumping established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the anti - dumping duty shall not exceed the margin of dumping established .


### if following an investigation pursuant to paragraph 2 , the measure expires , any duties collected from the date of the initiation of such investigation shall be repaid provided that this is requested from national customs authorities and granted by those authorities in accordance with the applicable union customs legislation concerning repayment and remission of duty . such repayment does not give rise to the payment of interest by the national customs authorities concerned . ### if following an investigation pursuant to paragraph 2 , the measure expires , any duties collected from the date of the initiation of such investigation shall be repaid with the accrued interest , provided that this is requested from national customs authorities and granted by those authorities in accordance with the applicable union customs legislation concerning repayment and remission of duty . such repayment does not give rise to the payment of interest by the national customs authorities concerned .


### the commission may , after consultation of the advisory committee , direct the customs authorities to take the appropriate steps to register imports , so that measures may subsequently be applied against those imports from the date of such registration . imports may be made subject to registration following a request from the community industry which contains sufficient evidence to justify such action . registration shall be introduced by regulation which shall specify the purpose of the action and , if appropriate , the estimated amount of possible future liability . imports shall not be made subject to registration for a period longer than nine months . ### article 14 shall be replaced by the following : 5 . the commission may , after consultation of the advisory committee , direct the customs authorities to take the appropriate steps to register imports , so that measures may subsequently be applied against those imports from the date of such registration . imports shall be made subject to registration following a request from the community industry which contains sufficient evidence to justify such action . imports may also be made subject to registration on the commission ' s own initiative . imports shall be made subject to registration from the date of initiation of the investigation where the complaint of the community industry contains a request for registration and sufficient evidence to justify such action . registration shall be introduced by regulation which shall specify the purpose of the action and , if appropriate , the estimated amount of possible future liability . imports shall not be made subject to registration for a period longer than nine months .


### in cases where the number of union producers , exporters or importers , types of product or transactions is large , the investigation may be limited to a reasonable number of parties , products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection , or to the largest representative volume of production , sales or exports which can reasonably be investigated within the time available . ### in cases where the number of union producers , exporters or importers , types of product or transactions is large , the investigation may be limited to a reasonable number of parties , products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection , or to the largest representative volume of production , sales or exports which can reasonably be investigated within the time available . sampling shall include all complainant union producers and it may also include non - complainant union producers .


### the union producers , importers and exporters and their representative associations , and representatives of the exporting country , may request information on the planned imposition of provisional duties . requests for such information shall be made in writing within the time limit prescribed in the notice of initiation . such information shall be provided to those parties , at least two weeks before the expiry of the deadline mentioned in article 7 for the imposition of provisional duties . such information shall include : ### the union producers , importers and exporters and their representative associations , and representatives of the exporting country , may request information on the planned imposition of provisional duties . requests for such information shall be made in writing within the time limit prescribed in the notice of initiation . such information shall be provided to those parties , at least 10 working days before the expiry of the deadline mentioned in article 7 for the imposition of provisional duties . such information shall include :


### xx ### article 18 is replaced by the following : “3 . the commission shall seek all information it considers necessary , including the available assessments , comments , decisions , recommendations and conclusions of the relevant supervisory bodies of the un , the ilo and other competent international organisations . these submissions shall be made public , in the interests of transparency , and shall serve as the starting point for the investigation into whether temporary withdrawal is justified for the reason referred to in article 15 . the commission may verify the information received with economic operators and the beneficiary country concerned . ”


### non - discrimination based on sex , racial or ethnic origin religion or belief , disability , age or sexual orientation and equality between women and men are values common to the member states . combating all forms of discrimination is an ongoing goal which requires coordinated action , including by the allocation of funding . ### respect for human dignity , freedom , democracy , equality , the rule of law and respect for human rights , including the rights of persons belonging to minorities are values common to the member states . combating all forms of discrimination is a goal which requires coordinated action , including by the allocation of funding .


### article 4 , article 8 and , article 9 and article 10 and shall not apply to a manufacturer which is responsible together with all of its connected undertakings for less than 500 new light commercial vehicles registered in the eu in the previous calendar year . ’ ### article 4 , article 8 and , article 9 and article 10 and shall not apply to a manufacturer which is responsible together with all of its connected undertakings for less than 700 new light commercial vehicles registered in the eu in the previous calendar year .


### as this regulation harmonises only certain sector - specific rules , it should be without prejudice to the general consumer protection rules , as established by union acts and national legislation implementing them . ### this regulation should be without prejudice to the general consumer protection rules , as established by union acts and national legislation implementing them , in particular directive 2011 / 83 / eu of the european parliament and of the council24a . __________________ 24a directive 2011 / 83 / eu of the european parliament and of the council of 25 october 2011 on consumer rights , amending council directive 93 / 13 / eec and directive 1999 / 44 / ec of the european parliament and of the council and repealing council directive 85 / 577 / eec and directive 97 / 7 / ec of the european parliament and of the council .


### national regulatory authorities play an essential role in ensuring that end - users are effectively able to exercise this freedom to avail of open internet access . to this end national regulatory authorities should have monitoring and reporting obligations , and ensure compliance of providers of electronic communications to the public and the availability of non - discriminatory internet access services of high quality which are not impaired by specialised services . in their assessment of a possible general impairment of internet access services , national regulatory authorities should take account of quality parameters such as timing and reliability parameters , levels and effects of congestion in the network , actual versus advertised speeds , performance of internet access services compared with specialised services , and quality as perceived by end - users . national regulatory authorities should be empowered to impose minimum quality of service requirements on all or individual providers of electronic communications to the public if this is necessary to prevent general impairment / degradation of the quality of service of internet access services . ### national regulatory authorities play an essential role in ensuring that end - users are effectively able to exercise this freedom to avail of open internet access . to this end national regulatory authorities should have monitoring and reporting obligations , and ensure compliance of providers of electronic communications to the public and the availability of non - discriminatory internet access services of high quality which are not impaired by specialised services . in their assessment of a possible general impairment of internet access services , national regulatory authorities should take account of quality parameters such as timing and reliability parameters , levels and effects of congestion in the network , actual versus advertised speeds , performance of internet access services compared with specialised services , and quality as perceived by end - users , taking utmost account of any guidelines issued by berec on the methods for measuring the speed of internet access services , the quality of service parameters to be measured and on the application of reasonable traffic management measures . national regulatory authorities should be empowered to impose minimum quality of service requirements on all or individual providers of electronic communications to the public if this is necessary to prevent general impairment / degradation of the quality of service of internet access services .


### in order to avoid bill shocks , end - users should be able to define maximum financial limits for the charges related to their usage of calls and internet access services . this facility should be available free of charge , with an appropriate notification that can be consulted again subsequently , when the limit is being approached . upon reaching the maximum limit , end - users should no longer receive or be charged for those services unless they specifically request the continued provision as agreed with the provider . ### in order to avoid bill shocks , end - users in tariffs billed by the time of usage or per unit used should be able to set maximum financial limits for the charges related to their usage of calls and internet access services . this facility should include an appropriate notification that can be consulted again subsequently , when the limit is being approached . upon reaching the maximum limit , end - users should no longer receive or be charged for those services unless they specifically request the continued provision as agreed with the provider .


### in order to support the provision of one - stop - shops and to facilitate a seamless switching experience for end - users , the switching process should be led by the receiving provider of electronic communications to the public . the transferring provider of electronic communications to the public should not delay or hamper the switching process . automated processes should be used as widely as possible and a high level of protection of personal data should be ensured . availability of transparent , accurate and timely information on switching should increase the end - users ' confidence in switching and make them more willing to engage actively in the competitive process . ### in order to facilitate a seamless switching experience for end - users , berec should be mandated to lay down guidelines setting out the respective responsibilities of the receiving and transferring provider in the switching and porting process , ensuring inter alia that the transferring provider of electronic communications to the public does not delay or hamper the switching process , that the process is automated as much as possible and that a high level of protection of personal data is ensured . the guidelines should also address the question of how to ensure continuity in the experience of end - users , including through identifiers such as email addresses through , for instance , the opportunity to opt for an email forwarding facility . availability of transparent , accurate and timely information on switching should increase the end - users ' confidence in switching and make them more willing to engage actively in the competitive process .


### harmonised rights of end - users ### users’ rights to open internet access


### national regulatory authorities shall , in good time before imposing any such requirements , provide the commission with a summary of the grounds for action , the envisaged requirements and the proposed course of action . this information shall also be made available to berec . the commission may , having examined such information , make comments or recommendations thereupon , in particular to ensure that the envisaged requirements do not adversely affect the functioning of the internal market . the envisaged requirements shall not be adopted during a period of two months from the receipt of complete information by the commission unless otherwise agreed between the commission and the national regulatory authority , or the commission has informed the national regulatory authority of a shortened examination period , or the commission has made comments or recommendations . national regulatory authorities shall take the utmost account of the commission’s comments or recommendations and shall communicate the adopted requirements to the commission and berec . ### national regulatory authorities shall , in good time before imposing any such requirements , provide the commission with a summary of the grounds for action , the envisaged requirements and the proposed course of action . this information shall also be made available to berec . the commission may , having examined such information , make comments or recommendations thereupon , in particular to ensure that the envisaged requirements do not adversely affect the functioning of the internal market . national regulatory authorities shall take the utmost account of the commission’s comments or recommendations and shall communicate the adopted requirements to the commission and berec . by berec , after consulting stakeholders and in close cooperation with the commission , shall lay down general guidelines for the application of reasonable traffic management measures . berec shall develop such guidelines on the basis of articles 23 and this article .


### contracts ### the title of article 20 is replaced by : ‘ information requirements for contracts’


### without prejudice to any minimum contractual period , member states shall ensure that conditions and procedures for contract termination do not act as a disincentive against changing service provider . ### article 30 is deleted


### member states shall ensure that all subscribers with numbers from the national telephone numbering plan who so request can retain their number independently of the undertaking providing the service in accordance with the provisions of part c of annex i . ### article 30 is replaced by the following : ‘ 1 . member states shall ensure that all subscribers with numbers from the national telephone numbering plan who so request can retain their number independently of the provider of electronic communications to the public providing the service in accordance with the provisions of part c of annex i . ’


### porting of numbers and their subsequent activation shall be carried out within the shortest possible time . in any case , subscribers who have concluded an agreement to port a number to a new undertaking shall have that number activated within one working day . without prejudice to the first subparagraph , competent national authorities may establish the global process of porting of numbers , taking into account national provisions on contracts , technical feasibility and the need to maintain continuity of service to the subscriber . in any event , loss of service during the process of porting shall not exceed one working day . competent national authorities shall also take into account , where necessary , measures ensuring that subscribers are protected throughout the switching process and are not switched to another provider against their will . member states shall ensure that appropriate sanctions on undertakings are provided for , including an obligation to compensate subscribers in case of delay in porting or abuse of porting by them or on their behalf . ### article 30 is replaced by the following : ‘ 4 . porting of numbers and their subsequent activation shall be carried out within the shortest possible time . for end - users who have concluded an agreement to port a number to a new provider that number shall be activated within one working day from the conclusion of such agreement . without prejudice to the first subparagraph , competent national authorities may establish the global process of switching and porting of numbers in accordance with the berec guidelines . they shall take into account necessary end - user protection throughout the switching process and the need to ensure the efficiency of such a process . in any event , loss of service during the process of porting shall not exceed one working day . end - users shall not be switched to another provider against their will . member states shall ensure that appropriate sanctions on undertakings are provided for , including an obligation to compensate subscribers in case of delay in porting or abuse of porting by them or on their behalf . ’


### member states shall ensure that contracts concluded between consumers and undertakings providing electronic communications services do not mandate an initial commitment period that exceeds 24 months . member states shall also ensure that undertakings offer users the possibility to subscribe to a contract with a maximum duration of 12 months . ### in article 30 is deleted


### ' 1 . member states shall ensure that , when subscribing to services providing connection to a public communications network and / or publicly available electronic communications services , consumers , and other end - users so requesting , have a right to a contract with an undertaking or undertakings providing such connection and / or services . the contract shall specify in a clear , comprehensive and easily accessible form at least : the identity and address of the undertaking ; the services provided , including in particular , — whether or not access to emergency services and caller location information is being provided , and any limitations on the provision of emergency services under article 26 , — information on any other conditions limiting access to and / or use of services and applications , where such conditions are permitted under national law in accordance with community law , — the minimum service quality levels offered , namely the time for the initial connection and , where appropriate , other quality of service parameters , as defined by the national regulatory authorities , — information on any procedures put in place by the undertaking to measure and shape traffic so as to avoid filling or overfilling a network link , and information on how those procedures could impact on service quality , — the types of maintenance service offered and customer support services provided , as well as the means of contacting these services , — any restrictions imposed by the provider on the use of terminal equipment supplied ; where an obligation exists under article 25 , the subscriber ' s options as to whether or not to include his or her personal data in a directory , and the data concerned ; details of prices and tariffs , the means by which up - to - date information on all applicable tariffs and maintenance charges may be obtained , payment methods offered and any differences in costs due to payment method ; the duration of the contract and the conditions for renewal and termination of services and of the contract , including : — any minimum usage or duration required to benefit from promotional terms , — any charges related to portability of numbers and other identifiers , — any charges due on termination of the contract , including any cost recovery with respect to terminal equipment , any compensation and the refund arrangements which apply if contracted service quality levels are not met ; the means of initiating procedures for the settlement of disputes in accordance with article 34 ; the type of action that might be taken by the undertaking in reaction to security or integrity incidents or threats and vulnerabilities . member states may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content , and on the means of protection against risks to personal security , privacy and personal data , referred to in article 21 and relevant to the service provided . ' ### article 20 is replaced by the following : ' 1 . member states shall ensure that , when subscribing to services providing connection to a public communications network and / or publicly available electronic communications services , consumers , and other end - users so requesting , have a right to a contract with an undertaking or undertakings providing such connection and / or services . the contract shall specify at least the following information . the identity , address and contact information of the undertaking and , if different , the address and contact information for any complaints ; the main characteristics of the services provided , including in particular , — the specific tariff plan or tariff plans to which the contract applies and , for each such tariff plan , the types of services offered , including the volumes of communications ; — whether and in which member state access to emergency services and caller location information is being provided , and any limitations on the provision of emergency services under article 26 , — the minimum service quality levels offered , namely the time for the initial connection and , where appropriate , other quality of service parameters , as defined by the national regulatory authorities , — the types of after - sales services , maintenance service and customer support services provided , the conditions and charges for these services , and the means of contacting these services , — any restrictions imposed by the provider on the use of terminal equipment supplied , including information on unlocking the terminal equipment and any charges involved if the contract is terminated ; where an obligation exists under article 25 , the subscriber ' s options as to whether or not to include his or her personal data in a directory , and the data concerned ; details of prices and tariffs including taxes and additional charges that may possibly be levied , the means by which up - to - date information on all applicable tariffs and maintenance charges may be obtained ; payment methods offered and any differences in costs due to payment method , and available facilities to safeguard bill transparency and monitor the level of consumption ; the duration of the contract and the conditions for renewal and termination of services and of the contract , including : — any minimum usage or duration required to benefit from promotional terms , — any charges related to switching and portability of numbers and other identifiers , including compensation arrangements for delay or abuse of switching ; — any charges due on termination of the contract , including any cost recovery with respect to terminal equipment and other promotional advantages , any compensation and the refund arrangements , including , where applicable , an explicit reference to statutory rights of the consumer which apply if contracted service quality levels are not met ; the means of initiating procedures for the settlement of disputes , including cross - border disputes , in accordance with article 34 ; details on how disabled end - users can obtain information on products and services designed for them ; the type of action that might be taken by the undertaking in reaction to security or integrity incidents or threats and vulnerabilities . member states may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content , and on the means of protection against risks to personal security , privacy and personal data , referred to in article 21 and relevant to the service provided . '


### member states shall ensure that , when subscribing to services providing connection to a public communications network and / or publicly available electronic communications services , consumers , and other end - users so requesting , have a right to a contract with an undertaking or undertakings providing such connection and / or services . the contract shall specify in a clear , comprehensive and easily accessible form at least : the identity and address of the undertaking ; the services provided , including in particular , — whether or not access to emergency services and caller location information is being provided , and any limitations on the provision of emergency services under article 26 , — information on any other conditions limiting access to and / or use of services and applications , where such conditions are permitted under national law in accordance with community law , — the minimum service quality levels offered , namely the time for the initial connection and , where appropriate , other quality of service parameters , as defined by the national regulatory authorities , — information on any procedures put in place by the undertaking to measure and shape traffic so as to avoid filling or overfilling a network link , and information on how those procedures could impact on service quality , — the types of maintenance service offered and customer support services provided , as well as the means of contacting these services , — any restrictions imposed by the provider on the use of terminal equipment supplied ; where an obligation exists under article 25 , the subscriber ' s options as to whether or not to include his or her personal data in a directory , and the data concerned ; details of prices and tariffs , the means by which up - to - date information on all applicable tariffs and maintenance charges may be obtained , payment methods offered and any differences in costs due to payment method ; the duration of the contract and the conditions for renewal and termination of services and of the contract , including : — any minimum usage or duration required to benefit from promotional terms , — any charges related to portability of numbers and other identifiers , — any charges due on termination of the contract , including any cost recovery with respect to terminal equipment , any compensation and the refund arrangements which apply if contracted service quality levels are not met ; the means of initiating procedures for the settlement of disputes in accordance with article 34 ; the type of action that might be taken by the undertaking in reaction to security or integrity incidents or threats and vulnerabilities . member states may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content , and on the means of protection against risks to personal security , privacy and personal data , referred to in article 21 and relevant to the service provided . ### article 20 is replaced by the following : ‘ 1 . member states shall ensure that , when subscribing to services providing connection to a public communications network and / or publicly available electronic communications services , consumers , and other end - users so requesting , have a right to a contract with an undertaking or undertakings providing such connection and / or services . the contract shall specify at least the following information . the identity , address and contact information of the undertaking and , if different , the address and contact information for any complaints ; the main characteristics of the services provided , including in particular , — the specific tariff plan or tariff plans to which the contract applies and , for each such tariff plan , the types of services offered , including the volumes of communications ; — whether and in which member state access to emergency services and caller location information is being provided , and any limitations on the provision of emergency services under article 26 , — the minimum service quality levels offered , namely the time for the initial connection and , where appropriate , other quality of service parameters , as defined by the national regulatory authorities , — the types of after - sales services , maintenance service and customer support services provided , the conditions and charges for these services , and the means of contacting these services , — any restrictions imposed by the provider on the use of terminal equipment supplied , including information on unlocking the terminal equipment and any charges involved if the contract is terminated before the end of the minimum contract period ; where an obligation exists under article 25 , the subscriber ' s options as to whether or not to include his or her personal data in a directory , and the data concerned ; details of prices and tariffs including taxes and additional charges that may possibly be levied , the means by which up - to - date information on all applicable tariffs and maintenance charges may be obtained ; payment methods offered and any differences in costs due to payment method , and available facilities to safeguard bill transparency and monitor the level of consumption ; the duration of the contract and the conditions for renewal and termination of services and of the contract , including : — any minimum usage or duration required to benefit from promotional terms , — any charges related to switching and portability of numbers and other identifiers , including compensation arrangements for delay or abuse of switching ; — any charges due on early termination of the contract , including any cost recovery with respect to terminal equipment and other promotional advantages , any compensation and the refund arrangements , including , where applicable , an explicit reference to statutory rights of the consumer which apply if contracted service quality levels are not met ; the means of initiating procedures for the settlement of disputes , including cross - border disputes , in accordance with article 34 ; details on how disabled end - users can obtain information on products and services designed for them ; the type of action that might be taken by the undertaking in reaction to security or integrity incidents or threats and vulnerabilities . member states may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content , and on the means of protection against risks to personal security , privacy and personal data , referred to in article 21 and relevant to the service provided . ’


### member states shall ensure that subscribers have a right to withdraw from their contract without penalty upon notice of modification to the contractual conditions proposed by the undertakings providing electronic communications networks and / or services . subscribers shall be given adequate notice , not shorter than one month , of any such modification , and shall be informed at the same time of their right to withdraw , without penalty , from their contract if they do not accept the new conditions . member states shall ensure that national regulatory authorities are able to specify the format of such notifications . ### article 20 is deleted


### member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to publish transparent , comparable , adequate and up - to - date information on applicable prices and tariffs , on any charges due on termination of a contract and on standard terms and conditions in respect of access to , and use of , services provided by them to end - users and consumers in accordance with annex ii . such information shall be published in a clear , comprehensive and easily accessible form . national regulatory authorities may specify additional requirements regarding the form in which such information is to be published . ### article 21 is replaced by the following : ‘ 1 . member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to publish transparent , comparable , adequate and up - to - date information on applicable prices and tariffs , on any charges due on termination of a contract and on standard terms and conditions in respect of access to , and use of , services provided by them to end - users in accordance with annex ii . such information shall be published in a clear , comprehensive and easily accessible form and shall be updated regularly . any differentiation in the conditions applied to consumers and other end - users shall be made explicit . national regulatory authorities may specify additional requirements regarding the form in which such information is to be published , including the introduction of language requirements so as to ensure that such information is easily understood by the end - user . member states shall ensure that providers of electronic communications to the public are obliged upon request to supply the information , to the relevant national regulatory authorities , in advance of its publication . ’


### member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to inter alia : provide applicable tariff information to subscribers regarding any number or service subject to particular pricing conditions ; with respect to individual categories of services , national regulatory authorities may require such information to be provided immediately prior to connecting the call ; inform subscribers of any change to access to emergency services or caller location information in the service to which they have subscribed ; inform subscribers of any change to conditions limiting access to and / or use of services and applications , where such conditions are permitted under national law in accordance with community law ; provide information on any procedures put in place by the provider to measure and shape traffic so as to avoid filling or overfilling a network link , and on how those procedures could impact on service quality ; inform subscribers of their right to determine whether or not to include their personal data in a directory , and of the types of data concerned , in accordance with article 12 of directive 2002 / 58 / ec ; and regularly inform disabled subscribers of details of products and services designed for them . if deemed appropriate , national regulatory authorities may promote self or co - regulatory measures prior to imposing any obligation . ### article 21 is replaced by the following : ‘ 3 . member states shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and / or publicly available electronic communications services to inter alia : provide applicable tariff information to subscribers regarding any number or service subject to particular pricing conditions ; with respect to individual categories of services , national regulatory authorities may require such information to be provided immediately prior to connecting the call ; provide end - users with access to emergency services and caller location information for all relevant services offered , any limitations on the provision of emergency services under article 26 , and any changes thereto ; provide information on internet access services , where offered , specifying the following : for fixed data links , the estimated available download and upload data speeds in the end - user ' s member state of residence , and for mobile data , the average estimated download and upload speeds that might be experienced from normal wireless network coverage , and the speed ranges that might be experienced ; details of unit data pricing plans , pricing plans for bulk data and any applicable thresholds . for data volumes above thresholds : unit or bulk pricing on an ad hoc or lasting basis and any data speed limitations that may be applied ; how end - users can monitor the current level of their consumption , and set any voluntary limitations ; a clear and comprehensible explanation as to how any data volume limitation , the actually available speed and other quality parameters , and the simultaneous use of specialised services , may in practice have an impact on the use of content , applications and services ; information on any procedures put in place by the provider to measure and shape traffic including an indication of the underlying communication inspection methods used for reasonable traffic management measures and information on how those procedures could impact on service quality , end - users’ privacy and the protection of personal data ; inform consumers , and end - users where applicable , of their right to determine whether or not to include their personal data in a directory , and of the types of data concerned , in accordance with article 12 of directive 2002 / 58 / ec ; and regularly inform disabled consumers , and end - users , where applicable , of details of products and services designed for them and the measures taken to ensure equivalence in access ; if deemed appropriate , national regulatory authorities may promote self - or co - regulatory measures prior to imposing any obligation . ’


### name and address of undertaking i . e . names and head office addresses of undertakings providing public communications networks and / or publicly available telephone services . ### in annex ii , point 1 is replaced by the following : ‘ 1 . name , address and contact information of undertaking i . e . names and head office addresses of undertakings providing public communications networks and / or publicly available telephone services . ’


### 2 . standard tariffs indicating the services provided and the content of each tariff element , and including details of standard discounts applied and special and targeted tariff schemes and any additional charges , as well as costs with respect to terminal equipment . ### in annex ii , point 2 . 2 is replaced by the following : ‘ 2 . 2 . for each tariff plan , the services provided and the relevant quality of service parameters , the applicable tariff plan and , for each such tariff plan , the types of services offered , including the volumes of communications , and any applicable charges , as well as costs with respect to terminal equipment . ’


### 5 . standard contract conditions , including any minimum contractual period , termination of the contract and procedures and direct charges related to the portability of numbers and other identifiers , if relevant . ### in annex ii , point 2 . 5 is replaced by the following : ‘ 2 . 5 . standard contract terms and conditions , including any minimum contractual period , the conditions for and any charges due on early termination of the contract , the procedures and direct charges related to the switching and portability of numbers and other identifiers , if relevant , and compensation arrangements for delay or abuse of switching . ’


### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results and stimulate training and mobility . ### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results , strive for innovation and stimulate training and mobility .


### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results and stimulate training and mobility . ### the union has the objective of strengthening its scientific and technological bases by achieving a european research area in which researchers , scientific knowledge and technology circulate freely , and encouraging the union ' s regions individually and the union as a whole to become more competitive , including in its industry . to pursue those objectives the union should carry out activities to implement research , technological development and demonstration , promote international cooperation , disseminate and optimise results and stimulate training and mobility .


### horizon 2020 - the framework programme for research and innovation in the european union , focuses on three priorities , namely generating excellent science in order to strengthen the union ' s world - class excellence in science , fostering industrial leadership to support business , including small and medium - sized enterprises and innovation and tackling societal challenges , in order to respond directly to the challenges identified in the europe 2020 strategy by supporting activities covering the entire spectrum from research to market . horizon 2020 should support all stages in the innovation chain , especially activities closer to the market including innovative financial instruments , as well as non - technological and social innovation , and aims to satisfy the research needs of a broad spectrum of union policies by placing emphasis on the widest possible use and dissemination of knowledge generated by the supported activities up to its commercial exploitation . the priorities of horizon 2020 should also be supported through a programme under the euratom treaty on nuclear research and training . ### horizon 2020 - the framework programme for research and innovation in the european union , focuses on three priorities , namely generating excellent science in order to strengthen the union ' s world - class excellence in science , fostering industrial leadership to support business , including small and medium - sized enterprises and innovation and tackling societal challenges , in order to respond directly to the challenges identified in the europe 2020 strategy by supporting activities covering the entire spectrum from basic and applied research to market and society . horizon 2020 should support all stages in the research and innovation chain , especially activities closer to society and the market including innovative financial instruments , as well as non - technological and social innovation , and activities that can promote social inclusion across communities , and aims to satisfy the research needs of a broad spectrum of union policies by placing emphasis on the widest possible use and dissemination of knowledge generated by the supported activities up to its social and / or commercial exploitation . the priorities of horizon 2020 should also be supported through a programme under the euratom treaty on nuclear research and training .


### simplification is a central aim of horizon 2020 which should be fully reflected in its design , rules , financial management and implementation . horizon 2020 should aim to attract the strong participation of universities , research centres , industry and specifically smes and be open to new participants , as it brings together the full range of research and innovation support in one common strategic framework , including a streamlined set of forms of support and uses rules for participation with principles applicable to all actions under the programme . simpler funding rules should reduce the administrative costs for participation and will contribute to a reduction of financial errors . ### simplification and clarity are a central aim of horizon 2020 which should be fully reflected in its design , rules , financial management and implementation . horizon 2020 should aim to attract the strong participation of universities , research centres , industry and specifically smes and be open to new participants , as it brings together the full range of research and innovation support in one common strategic framework , including a streamlined set of forms of support and uses rules for participation with principles applicable to all actions under the programme . simpler funding rules should reduce the administrative costs for participation and will contribute to a reduction of financial errors and discrepancies .


### simplification is a central aim of horizon 2020 which should be fully reflected in its design , rules , financial management and implementation . horizon 2020 should aim to attract the strong participation of universities , research centres , industry and specifically smes and be open to new participants , as it brings together the full range of research and innovation support in one common strategic framework , including a streamlined set of forms of support and uses rules for participation with principles applicable to all actions under the programme . simpler funding rules should reduce the administrative costs for participation and will contribute to a reduction of financial errors . ### simplification is a central aim of horizon 2020 which should be fully reflected in its design , rules , financial management and implementation . horizon 2020 should aim to attract the strong participation of universities , research centres , industry , public sector research and innovation agencies , social economy organisations , and specifically smes and be open to new participants , as it brings together the full range of research and innovation support in one common strategic framework , including a streamlined set of forms of support and uses rules for participation with principles applicable to all actions under the programme . simpler funding rules should reduce the administrative costs for participation and will contribute to a reduction of financial errors .


### the implementation of horizon 2020 should respond to the evolving opportunities and needs from science and technology , industry , policies and society . as such , the agendas should be set in close liaison with stakeholders from all sectors concerned , and sufficient flexibility should be allowed for new developments . external advice should be sought on a continuous basis during horizon 2020 , also making use of relevant structures such as european technology platforms , joint programming initiatives and the european innovation partnerships . ### the implementation of horizon 2020 should respond to the evolving opportunities and needs from science and technology , industry , policies and society . as such , the agendas should be set in close liaison with stakeholders from all sectors concerned , and sufficient flexibility should be allowed for new developments . external advice should be sought on a continuous basis during horizon 2020 , where possible making use of existing relevant structures such as european technology platforms , joint programming initiatives and the european innovation partnerships .


### with the aim to achieve the greatest possible impact of union funding , horizon 2020 is to develop closer synergies , which may also take the form of public - public partnerships , with national and regional programmes that support research and innovation . ### with the aim to achieve the greatest possible impact of union funding , it is essential for horizon 2020 to develop closer collaboration , which may take the form of public - public partnerships , but should however aim to prioritise the public interest , with regional , national and supra - national programmes that support research and innovation .


### horizon 2020 should promote cooperation with third countries based on common interest and mutual benefit . international cooperation in science , technology and innovation should be targeted to contribute to achieving the europe 2020 objectives to strengthen competitiveness , contribute to tackling societal challenges and support union external and development policies , including by developing synergies with external programmes and contributing to the union ' s international commitments such as the achievement of millennium development goals . ### horizon 2020 should promote cooperation with third countries based on common interest and mutual benefit . international cooperation in science , technology and innovation should be targeted to contribute to achieving the europe 2020 objectives to strengthen competitiveness , contribute to tackling societal challenges and support union external and development collaborative international research networks and policies , including by developing synergies with external programmes and contributing to the union ' s international commitments such as the achievement of millennium development goals .


### excellent science ; ### excellent science including basic and applied research in the humanities ;


### societal challenges . ### societal challenges including basic and applied research in social sciences .


### horizon 2020 shall contribute to building an economy based on knowledge and innovation across the whole union by leveraging sufficient additional research , development and innovation funding . thereby , it shall support the implementation of the europe 2020 strategy and other union policies , as well as the achievement and functioning of the european research area . the relevant performance indicators are set out in the introduction of annex i . ### horizon 2020 shall contribute to building a knowledge and innovation based economy across the whole union by leveraging sufficient additional research , development and innovation funding . thereby , it shall support the implementation of the europe 2020 strategy and other union policies , as well as the achievement and functioning of the european research area through specific exemplary actions fostering european research and innovation . the relevant performance indicators are set out in the introduction of annex i .


### in order to respond to unforeseen situations or new developments and needs , and to take into account the provisions of paragraph 3 of this article , the commission may , following the interim evaluation of horizon 2020 as referred to in article 26 of this regulation , within the annual budgetary procedure review the amounts set out for the priorities in paragraph 2 and the indicative breakdown by specific objectives within these priorities set out in annex ii and transfer appropriations between the priorities and specific objectives up to 10 % of the total initial allocation of each priority and up to 10 % of the initial indicative breakdown of each specific objective . this does not concern the amount set out for the direct actions of the joint research centre in paragraph 2 or the contribution to the european institute of innovation and technology set out in paragraph 3 . ### in order to respond to unforeseen situations or new developments and needs , and to take into account the provisions of paragraph 3 of this article , the commission may , following the interim evaluation of horizon 2020 as referred to in article 26 of this regulation , within the annual budgetary procedure review the amounts set out for the priorities in paragraph 2 and the indicative breakdown by specific objectives within these priorities set out in annex ii and transfer appropriations between the priorities and specific objectives up to 20 % of the total initial allocation of each priority and up to 20 % of the initial indicative breakdown of each specific objective . this does not concern the amount set out for the direct actions of the joint research centre in paragraph 2 .


### horizon 2020 shall be implemented in a manner ensuring that the priorities and actions supported are relevant to changing needs and take account of the evolving nature of science , technology , innovation , markets and society , where innovation includes business , organisational and social aspects . ### horizon 2020 shall be implemented in a manner ensuring that the priorities and actions supported are in keeping with the current teaching and research set - up and can also be adjusted in line with changing needs and take account of the evolving nature of science , technology , innovation , labour markets and society , where science includes any field of academic research and innovation includes socio - economic , cultural and organisational aspects .


### research activity intended to modify the genetic heritage of human beings which could make such changes heritable ; ### research activity intended to modify the human genome for purposes other than preventive , diagnostic or therapeutic ; as well as research activity intended to modify the genetic heritage of human beings which could make such changes heritable ;


### particular attention shall be paid to ensuring the adequate participation of , and innovation impact on , small and medium - sized enterprises in horizon 2020 . quantitative and qualitative assessments of sme participation shall be undertaken as part of the evaluation and monitoring arrangements . ### particular attention shall be paid to ensuring the increased participation of , and innovation impact on , the private sector , particularly small and medium - sized enterprises in horizon 2020 . this covers : assistance at all stages of the research cycle , from prototype to full implementation , in order to enable them to fulfil their research potentials , b ) providing special support for intellectual property rights negotiations in open innovation projects , c ) providing support measures to help bridge delays in grants , as cash flow remains a key concern for smes , d ) providing support measures for awareness - raising activities among smes . quantitative and qualitative assessments of private sector , and particularly sme participation shall be undertaken as part of the evaluation and monitoring arrangements .


### without prejudice to paragraph 3 , audits by the commission may be carried out up to four years after the final payment . ### without prejudice to paragraph 3 , audits by the commission may be carried out up to two years after the completion of a project .


### future and emerging technologies shall support collaborative research in order to extend europe ' s capacity for advanced and paradigm - changing innovation . it shall foster scientific collaboration across disciplines on radically new , high - risk ideas and accelerate development of the most promising emerging areas of science and technology as well as the union wide structuring of the corresponding scientific communities . ### future and emerging technologies shall support collaborative or cross - disciplinary research in order to extend europe ' s capacity for advanced and paradigm - changing innovation . it shall foster scientific collaboration across disciplines on radically new , high - risk ideas and accelerate development of the most promising emerging areas of science and technology as well as the union wide structuring of the corresponding scientific communities .


### health , demographic change and well - being ; ### health , demographic change and well - being , including through participation in sporting activities ;


### social sciences and humanities shall be an integral part of the activities to address all the challenges . in addition , the underpinning development of these disciplines shall be supported under the specific objective ‘ inclusive , innovative and secure societies’ . support will also focus on providing a strong evidence base for policy making at international , union , national and regional levels . given the global nature of many of the challenges , strategic cooperation with third countries shall be an integral part of each challenge . in addition , cross - cutting support for international cooperation shall be provided under the specific objective ‘ inclusive , innovative and secure societies’ . ### social sciences and humanities shall be an integral part of the activities to address all the challenges . in addition , the underpinning development of these disciplines shall be supported under the specific objective ‘ inclusive , educated , innovative and secure societies’ . support will also focus on providing a strong evidence base for policy making at international , union , national and regional levels . given the global nature of many of the challenges , strategic cooperation with third countries shall be an integral part of each challenge . in addition , cross - cutting support for international cooperation shall be provided under the specific objective ‘ inclusive , educated , innovative and secure societies’ .


### all the activities shall take a challenge - based approach , focusing on policy priorities without predetermining the precise choice of technologies or solutions that should be developed . the emphasis shall be on bringing together a critical mass of resources and knowledge across different fields , technologies and scientific disciplines in order to address the challenges . the activities shall cover the full cycle from research to market , with a new focus on innovation - related activities , such as piloting , demonstration , test - beds , support for public procurement , design , end - user driven innovation , social innovation and market take - up of innovations . ### all the activities shall take a challenge - based approach , in which basic science , applied research , knowledge transfer and innovation are important and interlinked components , focusing on policy priorities without predetermining the precise choice of technologies or solutions that should be developed . the emphasis shall be on bringing together a critical mass of resources and knowledge across different fields , enabling access to world - class research infrastructures , technologies and scientific disciplines in order to address the challenges . the activities shall cover the full cycle from research to market , with a fresh focus on basic and applied science and a new focus on knowledge transfer and innovation - related activities .


### all the activities shall take a challenge - based approach , focusing on policy priorities without predetermining the precise choice of technologies or solutions that should be developed . the emphasis shall be on bringing together a critical mass of resources and knowledge across different fields , technologies and scientific disciplines in order to address the challenges . the activities shall cover the full cycle from research to market , with a new focus on innovation - related activities , such as piloting , demonstration , test - beds , support for public procurement , design , end - user driven innovation , social innovation and market take - up of innovations . ### all the activities shall take a challenge - based approach , in which basic science , applied research , knowledge transfer and innovation are equally important and interlinked components , focusing on policy priorities without predetermining the precise choice of technologies or solutions that should be developed . the emphasis shall be on bringing together a critical mass of resources and knowledge across different fields , technologies and scientific disciplines in order to address the challenges . the activities shall cover the full cycle from research to market , with a new focus on innovation - related activities , such as piloting , demonstration , test - beds , support for public procurement , design , end - user driven innovation , social innovation and market take - up of innovations .


### the jrc ' s key competence areas will be energy , transport , environment and climate change , agriculture and food security , health and consumer protection , information and communication technologies , reference materials , and safety and security . ### the jrc ' s key competence areas will be energy , transport , environment and climate change , agriculture and food security , health and consumer protection , the protection of the historical , artistic and cultural heritage , information and communication technologies , reference materials , and safety and security .


### the aim is to enhance solidarity as well as social , economic and political inclusion and positive inter - cultural dynamics in europe and with international partners , through cutting - edge science and interdisciplinarity , technological advances and organisational innovations . humanities research can play an important role here . research shall support policymakers in designing policies that combat poverty and prevent the development of various forms of divisions , discriminations and inequalities in european societies , such as gender inequalities or digital or innovation divides , and with other world regions . it shall in particular feed into the implementation and the adaptation of the europe 2020 strategy and the broad external action of the union . specific measures shall be taken to unlock excellence in less developed regions , thereby widening participation in horizon 2020 . ### the aim is to enhance intercommunication as well as social , economic , political and cultural inclusion and positive inter - cultural dynamics in europe as well as to gain a greater understanding of societal changes in europe and with international partners , through cutting - edge science and interdisciplinarity , technological advances and organisational innovations . humanities research should play a crucial role here , including through research into the consequences of societal change for the well - being and quality of the lives of individuals , families and societies , and must therefore be properly funded . humanities research can also reveal , develop , preserve and designate the multidimensional european cultural heritage by creating new scientific disciplines , new innovation fields and jobs . there is a need for an increased knowledge base in the areas of social exclusion , health , demographic change and the ageing society , life course , family traditions , shared history and cultural heritage , physical exercise , migration and mobility , education and lifelong learning , multilingualism and governance dynamics . research in the field of human and social sciences can play an important role here . research shall support policymakers in designing policies and identifying activities that combat poverty and prevent the development of various forms of divisions , discriminations and inequalities in european societies , such as gender inequalities or digital or innovation divides , and with other world regions , for example on the basis of comparative studies of cultural and linguistic diversity and intercultural interaction . it shall in particular feed into the implementation and the adaptation of the europe 2020 strategy and the broad external action of the union . specific measures shall be taken to unlock excellence in less developed regions , thereby widening participation in horizon 2020 .


### the fundamental activity of the erc shall be to provide attractive long - term funding to support excellent investigators and their research teams to pursue ground - breaking , high - gain / high - risk research . ### the fundamental activity of the erc shall be to provide attractive long - term funding to support excellent investigators and their research teams to pursue ground - breaking , high - gain / high - risk research . from this point of view , research as a scientific procedure should be recognised without exception in all fields of human knowledge .


### erc funding shall be awarded in accordance with the following well - established principles . scientific excellence shall be the sole criterion on which erc grants are awarded . the erc shall operate on a ‘ bottom - up’ basis without predetermined priorities . the erc grants shall be open to individual teams of researchers of any age and from any country in the world , working in europe . and the erc shall aim to foster healthy competition across europe . ### erc funding shall be awarded in accordance with the following well - established principles . scientific excellence in any field of knowledge shall be the sole criterion on which erc grants are awarded . the erc shall operate on a ‘ bottom - up’ basis without predetermined priorities . the erc grants shall be open to individual teams of researchers of any age and from any country in the world , working in europe . and the erc shall aim to foster healthy competition across europe .


### the aims shall be to ensure the implementation and operation of the esfri and other world - class research infrastructures , including the development of regional partner facilities ; integration of and access to national research infrastructures ; and the development , deployment and operation of e - infrastructures . ### the aims shall be to ensure the implementation and operation of and transnational access to the esfri and other world - class research infrastructures ; funding of operational costs with european added value including the development of regional partner facilities ; integration of and access to national research infrastructures ; and the development , deployment and operation of e - infrastructures .


### advancing scientific knowledge of the potential impact of nanotechnologies and nanosystems on health or on the environment , and providing tools for risk assessment and management along the entire life cycle . ### advancing scientific knowledge of the potential impact of nanotechnologies and nanosystems on health or on the environment , and providing tools for risk assessment and management along the entire life cycle , and enabling people with disabilities to be more fully integrated into society .


### development of emerging technology areas such as synthetic biology , bioinformatics and systems biology , which hold great promise for completely novel applications . ### development of emerging technology areas such as systems biology , bioinformatics and synthetic biology , which hold great promise for completely novel applications .


### the proposed actions aim to complement national and regional business innovation policies and programmes , to foster cooperation between smes and other innovation - relevant actors , to bridge the gap between research / development and successful market uptake , to provide a more business innovation friendly environment , including demand - side measures , and support taking into account the changing nature of innovation processes , new technologies , markets and business models . ### the proposed actions aim to complement national and regional business innovation policies and programmes , to foster cooperation between smes , academic institutions , including those in the creative industries , which are well placed to take advantage of the internationalised business environment and other innovation - relevant actors , to bridge the gap between research / development and successful market uptake , to provide a more business innovation friendly environment , including demand - side measures , and support taking into account the changing nature of innovation processes , new technologies , markets and business models .


### smes shall be supported across horizon 2020 . for this purpose a dedicated sme instrument shall provide staged and seamless support covering the whole innovation cycle . the sme instrument shall be targeted at all types of innovative smes showing a strong ambition to develop , grow and internationalise . it shall be provided for all types of innovation , including service , non - technological and social innovations . the aim is to develop and capitalise on the innovation potential of smes by filling the gap in funding for early stage high risk research and innovation , stimulating innovations and increasing private - sector commercialisation of research results . ### smes shall be supported across horizon 2020 . for this purpose a dedicated sme instrument shall provide staged and seamless support covering the whole innovation cycle . the sme instrument shall be targeted at all types of innovation in smes showing a strong ambition to develop , grow and internationalise . it shall be provided for all types of innovation , including service , non - technological and social innovations . the aim is to develop and capitalise on the innovation potential of smes by filling the gap in funding for early stage high risk research and innovation , stimulating innovations and increasing private - sector commercialisation of research results .


### supporting market - driven innovation to improve the framework conditions for innovation and tackling the specific barriers preventing , in particular , the growth of innovative smes . ### supporting market - driven innovation to improve the framework conditions for innovation and tackling the specific barriers preventing , in particular , the growth of innovation in smes .


### successful efforts to prevent , manage , treat and cure disease , disability and reduced functionality are underpinned by the fundamental understanding of their determinants and causes , processes and impacts , as well as factors underlying good health and wellbeing . effective sharing of data and the linkage of these data with large scale cohort studies is also essential , as is the translation of research findings into the clinic , in particular through the conduct of clinical trials . ### successful efforts to prevent , manage , treat and cure disease , disability and reduced functionality are underpinned by the fundamental understanding of their determinants and causes , processes and impacts , as well as factors underlying good health and wellbeing , including the impact of social and cultural factors and creative activities on individuals’ daily lives . effective sharing of data and the linkage of these data with large scale cohort studies is also essential , as is the translation of research findings into the clinic , in particular through the conduct of clinical trials .


### specific activities shall include : understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . ### specific activities shall include : ensuring long - term research programmes to ensure the full innovation cycle is covered , understanding the determinants of health , improving health promotion and disease prevention ; understanding disease and improving diagnosis ; developing effective screening programmes and improving the assessment of disease susceptibility ; improving surveillance and preparedness ; developing better preventive vaccines ; using in - silico medicine for improving disease management and prediction ; treating disease ; transferring knowledge to clinical practice and scalable innovation actions ; better use of health data ; active ageing , independent and assisted living ; individual empowerment for self - management of health ; promotion of integrated care ; improving scientific tools and methods to support policy making and regulatory needs ; coordination to ensure sharing of expertise and knowledge between clinical disciplines given the interconnectiveness of diseases and increasing co - morbidity and in order to exchange knowledge , share resources and save costs ; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice , and innovative technologies and approaches . where appropriate these activities shall take account of divergences amongst gender and genetic groupings .


### to achieve these reductions , significant investments need to be made in research , development , demonstration and market roll - out of efficient , safe and reliable low - carbon energy technologies and services . these must go hand in hand with non - technological solutions on both the supply and demand sides . all this must be part of an integrated low - carbon policy , including mastering key enabling technologies , in particular ict solutions and advanced manufacturing , processing and materials . the goal is to produce efficient energy technologies and services that can be taken up widely on european and international markets and to establish intelligent demand - side management based on an open and transparent energy trade market and intelligent energy efficiency management systems . ### to achieve these reductions , significant investments need to be made in research , development , demonstration and market roll - out of efficient , safe and reliable low - carbon energy technologies and services . these must go hand in hand with non - technological solutions on both the supply and demand sides . furthermore , these investments must be accompanied by a high - profile public - awareness campaign to ensure that european citizens lead the way in introducing the necessary environmental , social and cultural changes . all this must be part of an integrated low - carbon policy , including mastering key enabling technologies , in particular ict solutions and advanced manufacturing , processing and materials . the goal is to produce efficient energy technologies and services that benefit society and can be taken up widely on european and international markets and to establish intelligent demand - side management based on an open and transparent energy trade market and intelligent energy efficiency management and monitoring systems .


### to achieve these reductions , significant investments need to be made in research , development , demonstration and market roll - out of efficient , safe and reliable low - carbon energy technologies and services . these must go hand in hand with non - technological solutions on both the supply and demand sides . all this must be part of an integrated low - carbon policy , including mastering key enabling technologies , in particular ict solutions and advanced manufacturing , processing and materials . the goal is to produce efficient energy technologies and services that can be taken up widely on european and international markets and to establish intelligent demand - side management based on an open and transparent energy trade market and intelligent energy efficiency management systems . ### to achieve these reductions , significant investments need to be made in research , development , demonstration and market roll - out of efficient , safe and reliable low - carbon energy technologies , including gas , and services . these must go hand in hand with non - technological solutions on both the supply and demand sides . all this must be part of an integrated low - carbon policy , including mastering key enabling technologies , in particular ict solutions and advanced manufacturing , processing and materials . the goal is to produce efficient energy technologies and services that can be taken up widely on european and international markets and to establish intelligent demand - side management based on an open and transparent energy trade market and intelligent energy efficiency management systems .


### activities shall focus on research , development and full scale demonstration - of innovative renewables and carbon capture and storage technologies offering larger scale , lower cost , environmentally safe technologies with higher conversion efficiency and higher availability for different market and operating environments . ### activities shall focus on research , development and full scale demonstration - of innovative renewables , flexible and efficient fossil fuel power plants including carbon capture and storage technologies offering larger scale , lower cost , environmentally safe technologies with higher conversion efficiency , adequate flexibility for back - up power generation and higher availability for different market and operating environments .


### the development and implementation of research and innovation agendas through public–private partnerships , the building of effective industry - academia links , the leveraging of additional investments , the access to risk finance , standardisation and the support to pre - commercial procurement and the procurement of innovative products and services are all aspects that are essential in addressing competitiveness . ### the development and implementation of research and innovation agendas through european technology platforms and public–private partnerships , the building of effective industry - academia links , the leveraging of additional investments , the access to risk finance , standardisation and the support to pre - commercial procurement and the procurement of innovative products and services are all aspects that are essential in addressing competitiveness .


### in deciding on the design of new terminals , and as part of major refurbishments , terminal managing bodies should , where possible , take into account the needs of disabled persons and persons with reduced mobility . in any case , terminal managing bodies should designate points where such persons can notify their arrival and need for assistance . ### in deciding on the design of new terminals , and as part of major refurbishments , terminal managing bodies should take into account the needs of disabled parsons and persons with reduced mobility . in any case , terminal managing bodies should designate points where such persons can notify their arrival and need for assistance .


### nothing in this regulation shall be understood as constituting technical requirements imposing obligations on carriers or terminal managing bodies to modify or replace buses or coaches or infrastructure or equipment at bus stops and terminals . ### nothing in this regulation shall be understood to constitute technical requirements imposing obligations on carriers to modify or replace buses or coaches .


### in the event of an accident arising out of the use of the bus or coach , the carrier shall provide reasonable assistance with regard to the passengers ' immediate practical needs following the accident . any assistance shall not constitute recognition of liability . ### in the event of an accident arising out of the use of the bus or coach , the carrier shall provide reasonable assistance with regard to the passengers ' immediate practical needs following the accident .


### subject to the access conditions provided for in article 11 , carriers and terminal managing bodies shall , within their respective areas of competence , at terminals designated by member states , provide assistance free of charge to disabled persons and persons with reduced mobility as specified in part of annex i . ### subject to the access conditions provided for in article 11 , terminal managing bodies shall , at terminals designated by member states , provide assistance free of charge to disabled persons and persons with reduced mobility , at least to the extent specified in part of annex i .


### subject to the access conditions provided for in article 11 , carriers shall , on board buses and coaches , provide assistance free of charge to disabled persons and persons with reduced mobility as specified in part of annex i . ### subject to the access conditions provided for in article 11 , carriers shall , on board buses and coaches , provide assistance free of charge to disabled persons and persons with reduced mobility at least to the extent specified in part of annex i .


### it is also necessary to allow the european parliament to be represented on the agency’s administrative board as an observer , in view of the fact that regulation no 683 / 2008 highlighted the usefulness of close cooperation between the european parliament , the council and the commission . in order to ensure good governance of the programmes , the executive director’s term of office should therefore be reduced from five to four years . ### it is also necessary to allow the european parliament to be represented on the agency’s administrative board , in view of the fact that regulation no 683 / 2008 highlighted the usefulness of close cooperation between the european parliament , the council and the commission . in order to ensure good governance of the programmes , the executive director’s term of office should therefore be reduced from five to four years .


### ' ticket price ' means the full price paid for a ticket and including the air fare , and all applicable taxes , charges , surcharges and fees paid for all optional and non - optional services included in the ticket ; ### ' ticket price ' means the full price paid for a ticket and including the air fare , all applicable taxes , charges , surcharges and fees paid for all optional and non - optional services included in the ticket related to the air transport part of the journey .


### reimbursement within seven days of the passenger ' s request , by the means provided for in article 7 , of the flight price , for the part or parts of the journey not made , and for the part or parts already made if the flight is no longer serving any purpose in relation to the passenger ' s original travel plan , together with , when relevant , ### reimbursement within seven working days of the passenger ' s request , by the means provided for in article 7 , of the ticket price , for the part or parts of the journey not made , and for the part or parts already made if the flight is no longer serving any purpose in relation to the passenger ' s original travel plan , together with , when relevant ,


### if a passenger wants to make a complaint to the air carrier with regard to his rights under this regulation , he shall submit it within 3 months from the date on which the flight was performed or was scheduled to be performed . within 7 days of receiving the complaint , the carrier shall confirm the receipt of the complaint to the passenger . within two months of receiving the complaint , the carrier shall provide a full answer to the passenger . ### if a passenger wants to make a complaint to the air carrier with regard to his rights under this regulation , he shall submit it within 3 months from the date on which the flight was performed or was scheduled to be performed . within 7 working days of receiving the complaint , the carrier shall confirm the receipt of the complaint to the passenger . within two months of receiving the complaint , the carrier shall provide a full answer to the passenger .


### ' threat of serious injury ' means serious injury that is clearly imminent ; a determination of the existence of a threat of serious injury shall be based on facts and not merely on allegation , conjecture or remote possibility ; forecasts , estimations and analysis made on the basis of factors laid down in article 4 , paragraph 5 , shall inter alia , be admissible to determine the existence of a threat of serious injury ; ### ' threat of serious injury ' means serious injury that is clearly imminent ; a determination of the existence of a threat of serious injury shall be based on verifiable facts and not merely on allegation , conjecture or remote possibility ; forecasts , estimations and analysis made on the basis of factors laid down in article 4 , paragraph 5 , shall inter alia , be admissible to assess the proven existence of a threat of serious injury ;


### where bilateral safeguard measures are deemed unnecessary the investigation and proceeding shall be terminated on the basis of the procedure referred to in article 11 . ### where bilateral safeguard measures do not meet the requirements of this regulation , the investigation and proceeding shall be terminated on the basis of the procedure referred to in article 11 .


### for the smooth functioning of direct payments in calendar year 2013 , it is necessary to extend the net ceilings set out for calendar year 2012 to 2013 and adjust them where necessary , in particular as regards the increases resulting from the phasing - in of direct payments in the new member states and the cessation of voluntary modulation provided for in council regulation no 378 / 2007 of 27 march 2007 laying down rules for voluntary modulation of direct payments provided for in regulation no 1782 / 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers . ### for the smooth functioning of direct payments in calendar year 2013 , it is necessary to extend the net ceilings set out for calendar year 2012 to 2013 and adjust them where necessary , in particular as regards the increases resulting from the phasing - in of direct payments in the new member states .


### a description of the company ' s diversity policy for its administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background , the objectives of this diversity policy , how it has been implemented and the results in the reporting period . if the company has no such policy , the statement shall contain a clear and reasoned explanation as to why this is the case . ### a description of the large company ' s diversity policy for its administrative , management and supervisory bodies can be provided on a voluntary basis and may be seen as an example of good practice in the business and consumer community . it may include aspects such as age , gender , geographical diversity , educational and professional background , the objectives of this diversity policy , how it has been implemented and the results in the reporting period . if the company has no such policy , the statement shall contain a clear and reasoned explanation as to why this is the case . under no circumstances shall a large company be subject to administrative and financial sanctions for non - compliance , or be forced to disclose employee wages , or any other sensitive data , as long as it is in compliance with data protection laws .


### decision no 768 / 2008 / ec of the european parliament and of the council of 9 july 2008 on a common framework for the marketing of products provides common principles and reference provisions for the purposes of legislation based on the new approach principles . in order to ensure consistency with other sectoral product legislation , it is appropriate to align certain provisions of this directive to that decision , in so far as sectoral specificities do not require a different solution . therefore , certain definitions , the general obligations of economic operators , the presumption of conformity , formal objections against harmonised standards , rules on ce marking , requirements for conformity assessment bodies and notification procedures and the provisions concerning procedures dealing with products presenting a risk should be aligned to that decision . ### decision no 768 / 2008 / ec of the european parliament and of the council of 9 july 2008 on a common framework for the marketing of products provides common principles and reference provisions for the purposes of legislation based on the new approach principles . in order to ensure consistency with other sectoral product legislation , it is appropriate to align certain provisions of this directive to that decision , in so far as sectoral specificities do not require a different solution . therefore , certain definitions , the general obligations of economic operators , the presumption of conformity , rules on ce marking , requirements for conformity assessment bodies and notification procedures and the provisions concerning procedures dealing with products presenting a risk should be aligned to that decision . regulation no [ . . . / . . . ] of the european parliament and of the council of . . . on european standardisation1* provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this directive . _____________ 1 oj l . . . . * oj : please insert the number , date and oj reference of that regulation .


### options for further reducing the exhaust emission limits of recreational marine engines have been assessed in the report on the possibilities of further improving the environmental characteristics of recreational craft engines , submitted pursuant to article 2 of directive 2003 / 44 / ec , amending directive 94 / 25 / ec relating to recreational craft19 . this report concluded that it is appropriate to set stricter limits than those set in directive 2003 / 44 / ec . those limits should be set at a level that reflects the technical development of cleaner marine engine technologies and that allows a development towards the harmonisation of exhaust emission limits worldwide . the co - limits , however , should be raised in order to allow the significant decrease of other air pollutants while ensuring that the compliance costs remain proportionate . ### options for further reducing the exhaust emission limits of recreational marine engines have been assessed in the report on the possibilities of further improving the environmental characteristics of recreational craft engines , submitted pursuant to article 2 of directive 2003 / 44 / ec , amending directive 94 / 25 / ec relating to recreational craft19 . this report concluded that it is appropriate to set stricter limits than those set in directive 2003 / 44 / ec . those limits should be set at a level that reflects the technical development of cleaner marine engine technologies and that allows a development towards the harmonisation of exhaust emission limits worldwide . the co - limits , however , should be raised in order to allow the significant decrease of other air pollutants while ensuring that the compliance costs remain proportionate . the co - limits as proposed are part of a strategy to achieve the most stringent overall emissions reductions , to reflect technological feasibility and to achieve the fastest possible implementation while ensuring the socio - economic impact on this economic sector is acceptable .