### each member state shall designate a competent authority responsible for the implementation of the security of gas supply measures provided in this regulation . the measures shall include the biennial risk assessment , the establishment of the preventive action plans , the establishment of the emergency plan , and the continuous monitoring of security of gas supply at national level . competent authorities shall cooperate with each other to prevent a supply disruption and to limit damages in case it occurs . ### each member state shall designate on transparent terms an independent competent authority responsible for the implementation of the security of gas supply measures in line with the provisions of this regulation . the measures shall include the biennial risk and impact assessment including geopolitical risks , the establishment of the preventive action plans , the establishment of the emergency plan , and the continuous monitoring of security of gas supply at national level . competent authorities shall cooperate with each other to prevent a supply disruption and to limit damages in case it occurs .


### in addition to the monitoring and reporting obligations provided for in article 5 of the gas directive the competent authority shall publish and forward to the commission a report by 31 july each year containing the following data : calculation of n - 1 indicator and data necessary for such calculation , progress made in investments needed to cope with n - 1 , country specific difficulties encountered in the implementation new alternative solutions ; annual amounts , durations and supply country covered by gas supply import contracts ; maximal interconnection capacity of each entry and exit points to and from the gas systems ; the main elements of the relevant intergovernmental agreements concluded with third countries . ### in addition to the monitoring and reporting obligations provided for in article 5 of the gas directive the competent authority shall forward to the commission a report by 31 july each year containing the following data : calculation of n - 1 indicator and data necessary for such calculation ; on an aggregated basis , annual amounts , durations and supply country covered by gas supply import contracts ; maximal interconnection capacity of each entry and exit points to and from the gas systems ; the main elements of the relevant intergovernmental agreements concluded with third countries .


### following the recommendation of the commission referred to in article 4 or in situation referred to in article 4 , the obligation set out in paragraph 1 may be fulfilled at the regional level . the n - 1 standard shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by demand side measures . ### following the recommendation of the commission referred to in article 4 or in the situation referred to in article 4 , the calculation set out in paragraph 1 may be carried out at the regional level . in its calculation of the n - 1 indicator , the competent authority shall be allowed to demonstrate in the preventive action plan referred to in article 5 that a supply disruption may be sufficiently and timely compensated for by specific measures , including demand side measures .


### this regulation establishes measures aimed at safeguarding the security of gas supply so as to ensure the proper and continuous functioning of the internal market for gas by providing for a clear definition and attribution of responsibilities and for a coordination of the response at the level of the member states and the community regarding both preventive action and the reaction to concrete disruptions of supply . ### this regulation establishes measures aimed at safeguarding the security of gas supply so as to ensure the proper and continuous functioning of the internal market for gas , and exceptional measures to be implemented where the market cannot deliver the required gas supply , by providing for a clear definition and attribution of responsibilities and for a coordination of the response at the level of the member states and the union regarding both preventive action and the reaction to concrete disruptions of supply in a spirit of solidarity between the member states .


### sufficient gas infrastructure within a member state and across the community is essential for tackling supply interruptions . common minimum criteria on security of gas supply should ensure a level playing field for security of gas supply and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce demand appreciably to react to a supply disruption . ### sufficient gas infrastructure within a member state and across the union is essential for tackling supply interruptions . risk and impact assessments based on a common methodology should ensure effective and efficient implementation of minimum criteria on security of gas supply and a level playing field for security of gas supply while taking into account national or regional specificities and should create significant incentives to build the necessary infrastructure and to improve the level of preparedness in case of crisis . demand side measures such as fuel switching may have a valuable role to play in ensuring energy security where they can be applied quickly and reduce gas demand appreciably to react to a supply disruption .


### the competent authorities and the commission shall ensure the confidentiality of commercially sensitive information . ### the competent authorities and the commission shall at all times ensure the confidentiality of commercially sensitive information submitted to them in application of this regulation .


### the competent authority shall allow the natural gas undertakings to meet these criteria on a regional or community level and shall not require that these standards are met based on infrastructure located only within its territory . ### the competent authorities shall be allowed to calculate these indicators on a regional or union level and they shall not be required to calculate these indicators only within their territory .


### to strengthen the solidarity between member states in the case of a community emergency and in particular to support member states which are exposed to less favourable geographical or geological conditions , member states should devise specific measures to exercise solidarity , including measures such as commercial agreements between natural gas undertakings , compensation mechanisms , increased gas exports or increased releases from storages . solidarity measures may be particularly appropriate between member states for which the commission recommends the establishment of joint preventive actions plans or emergency plans at regional level . ### to strengthen the solidarity between member states in the case of a union emergency and in particular to support member states which are exposed to less favourable geographical or geological conditions , member states should devise measures to exercise solidarity . natural gas undertakings should devise measures such as commercial agreements , which may comprise increased gas exports or increased releases from storages . it is important to encourage the conclusion of prior arrangements between natural gas undertakings . natural gas undertakings should always be compensated in a fair and equitable manner for any measures they are asked to take in preparation for an emergency situation . obligations for solidarity measures should be limited to the supply of household customers . solidarity measures may be particularly appropriate between member states for which the commission recommends the establishment of joint preventive actions plans or emergency plans at regional level .


### the failure of the largest single gas infrastructure or gas supply source , the so - called n - 1 principle , is a realistic scenario . using the failure of such infrastructure or supply source as a benchmark of what member states should be able to compensate is a valid starting point for ensuring their security of gas supply . ### the failure of the largest single gas infrastructure , the so - called n - 1 principle , may well be a realistic scenario . the failure of such infrastructure is one of the scenario analyses that may help in evaluating a member state’s security of supply .


### ‘ the data subject ' s consent’ means any freely given specific , informed and explicit indication of his or her wishes by which the data subject , either by a statement or by a clear affirmative action , signifies agreement to personal data relating to them being processed ; ### ' the data subject ' s consent ' means any freely given specific and informed indication of his or her wishes by which the data subject signifies agreement to personal data relating to them being processed ;


### in the case of a personal data breach , the controller shall without undue delay and , where feasible , not later than 24 hours after having become aware of it , notify the personal data breach to the supervisory authority . the notification to the supervisory authority shall be accompanied by a reasoned justification in cases where it is not made within 24 hours . ### in the case of a personal data breach , the controller shall without undue delay notify the personal data breach to the supervisory authority .


### ‘ the data subject ' s consent’ means any freely given specific , informed and explicit indication of his or her wishes by which the data subject , either by a statement or by a clear affirmative action , signifies agreement to personal data relating to them being processed ; ### ' the data subject ' s consent ' means any freely given specific , informed and explicit indication of his or her wishes by which the data subject , either by a statement or by a clear affirmative action , signifies agreement to personal data relating to them being processed ; by ' clear affirmative action ' is meant any unequivocal action that is the result of a choice and that implies , for its complete execution , a necessary data processing ;


### consent should be given explicitly by any appropriate method enabling a freely given specific and informed indication of the data subject ' s wishes , either by a statement or by a clear affirmative action by the data subject , ensuring that individuals are aware that they give their consent to the processing of personal data , including by ticking a box when visiting an internet website or by any other statement or conduct which clearly indicates in this context the data subject ' s acceptance of the proposed processing of their personal data . silence or inactivity should therefore not constitute consent . consent should cover all processing activities carried out for the same purpose or purposes . if the data subject ' s consent is to be given following an electronic request , the request must be clear , concise and not unnecessarily disruptive to the use of the service for which it is provided . ### consent should be given by any appropriate method enabling a freely given specific and informed indication of the data subject ' s wishes , either by a statement or by a clear affirmative action by the data subject , ensuring that individuals are aware that they give their consent to the processing of personal data , including by ticking a box when visiting an internet website or by any other statement or conduct which clearly indicates in this context the data subject ' s acceptance of the proposed processing of their personal data . silence or inactivity should therefore not constitute consent . consent should cover all processing activities carried out for the same purpose or purposes . if the data subject ' s consent is to be given following an electronic request , the request must be clear , concise and not unnecessarily disruptive to the use of the service for which it is provided .


### consent should be given explicitly by any appropriate method enabling a freely given specific and informed indication of the data subject ' s wishes , either by a statement or by a clear affirmative action by the data subject , ensuring that individuals are aware that they give their consent to the processing of personal data , including by ticking a box when visiting an internet website or by any other statement or conduct which clearly indicates in this context the data subject ' s acceptance of the proposed processing of their personal data . silence or inactivity should therefore not constitute consent . consent should cover all processing activities carried out for the same purpose or purposes . if the data subject ' s consent is to be given following an electronic request , the request must be clear , concise and not unnecessarily disruptive to the use of the service for which it is provided . ### consent should be given by any appropriate method enabling a freely given , specific and informed indication of the data subject ' s wishes . consent can be given either by a statement or by a clear affirmative action by the data subject , ensuring that individuals are aware that they give their consent to the processing of personal data , including by ticking a box when visiting an internet website or by any other statement or conduct such as selecting default settings , which clearly indicates in the specific context the data subject ' s agreement . silence or inactivity should not constitute consent . any request to give consent electronically must be clear , concise and not unnecessarily disruptive or burdensome to the data subject and to the use of the service for which it is provided , and should facilitate clear choice .


### the maximum rate of co - financing shall be set at 60 % of the total eligible costs for the multi programmes . the remaining expenditure shall be borne exclusively by proposing organisations . ### the maximum rate of co - financing shall be set at 75 % of the total eligible costs for the multi programmes . non - recoverable vat that has been genuinely and definitively paid by beneficiaries shall be regarded as eligible expenditure . the remaining expenditure shall be borne exclusively by proposing organisations .


### the union ' s financial contribution to simple programmes shall not exceed 50&#160 ; % of the eligible expenditure . the remaining expenditure shall be borne exclusively by proposing organisations . ### the union ' s financial contribution to simple programmes shall not exceed 75&#160 ; % of the eligible expenditure . non - recoverable vat that has been genuinely and definitively paid by beneficiaries shall be regarded as eligible expenditure . the remaining expenditure shall be borne exclusively by proposing organisations .


### the agricultural products listed in annex i to the treaty on the functioning of the european union , excluding the fishery and aquaculture products listed in annex 1 to regulation no [ com416 ] of the european parliament and of the council19 and tobacco ; __________________ 19 regulation no [ com . ### the agricultural products listed in annex i to the treaty on the functioning of the european union , excluding tobacco ; __________________ 19 regulation no [ com .


### to launch the programming period , the commission and each member state shall have a policy dialogue on the national requirements and the contribution that the union budget could provide to achieving these requirements , bearing in mind the base line situation in the member state concerned and the objectives of the specific regulations . the policy dialogue shall result in the conclusion of agreed minutes or an exchange of letters which shall identify the specific needs and priorities of the member state concerned and serve as the framework for the preparation of the national programmes . ### to launch the programming period , the commission and each member state shall have a policy dialogue , in consultation with the european parliament , on the national requirements and the contribution that the union budget could provide to achieving these requirements , bearing in mind the base line situation in the member state concerned and the objectives of the specific regulations . the policy dialogue shall result in the conclusion of agreed minutes or an exchange of letters which shall identify the specific needs and priorities of the member state concerned and serve as the framework for the preparation of the national programmes .


### with effect from two months after the entry into force of this regulation , payment services providers shall not offer or request for cross - border debit card transactions a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0 , 2 % of the value of the transaction . ### with effect from two months after the entry into force of this regulation , payment services providers shall not offer or request for cross - border transactions with a debit card a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of , on average , more than 0 , 2 % of the value of the transaction .


### with effect from two months after the entry into force of this regulation , payment services providers shall not offer or request for cross - border credit card transactions a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0 , 3 % of the value of the transaction . ### with effect from two months after the entry into force of this regulation , payment services providers shall not offer or request for cross - border transactions with a credit card a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of , on average , more than 0 , 3 % of the value of the transaction .


### the eu declaration of conformity shall have the model structure set out in annex iv of this directive , shall contain the elements specified in the module a as set out in annex iii of this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the electrical equipment is placed or made available . ### the eu declaration of conformity shall have the model structure set out in annex iv of this directive , shall contain the elements specified in the module a as set out in annex iii of this directive and shall be continuously updated . it may be translated , upon request , into the language or languages required by the member state in which market the electrical equipment is placed or made available .


### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20135 aims at achieving a greater impact on research and innovation by contributing to the strengthening of public - public partnerships , including through union participation in programmes undertaken by several member states in accordance with article 185 of the treaty . __________________ 5 oj … [ h2020 fp ] ### horizon 2020 - the framework programme for research and innovation established by regulation no … / 2013 of the european parliament and of the council of … 20135 aims at achieving a greater impact on research and innovation by developing closer synergies , increasing coordination and avoiding unnecessary duplication with international , national and regional research programmes . public - public partnerships , including union participation in programmes undertaken by several member states in accordance with article 185 of the treaty should achieve these goals , meet the conditions specified in that regulation in particular those in article 20 and fully respect the general principles in particular on open access and transparency . __________________ 5 oj … [ h2020 fp ]


### where the person is a child , member states shall ensure that the child’s legal representative or another adult , depending on the interest of the child , is informed as soon as possible of the deprivation of liberty and the reasons pertaining thereto , unless it would be contrary to the best interests of the child , in which case another appropriate adult shall be informed . ### where the person is a minor , member states shall ensure that the minor’s legal representative or another adult , depending on the interest of the minor , is informed as soon as possible of the deprivation of liberty and the reasons pertaining thereto , unless it would be contrary to the best interests of the minor , in which case another appropriate adult shall be informed .


### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , and food for special medical purposes should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate . ### to ensure legal certainty , definitions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 should be transferred to this regulation . however , the definitions of infant formulae and follow - on formulae , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure for intense muscular effort and foodstuffs for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level , as appropriate .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec , directive 96 / 8 / ec and regulation no 41 / 2009 , as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods referred to in article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for foods for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of regulation no 41 / 2009 . in addition , the statement ‘ gluten - free’ may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of regulation no 41 / 2009 which do not allow the use of the statement ‘ very low gluten’ for these foods . such foods for specialized nutrition intended for people intolerant to gluten should be maintained in this regulation , as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for foods for special dietary use for persons intolerant to gluten . also the conditions of use of the claim ‘ gluten - free’ for foods for normal consumption should be maintained in the regulation no 41 / 2009 .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 and shall provide adequate consumer information , must not be misleading and shall not attribute properties to such products for the prevention , treatment or cure of human disease , or imply such properties .


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure of intense muscular effort and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure of intense muscular effort and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### the dissemination of any useful information or recommendations with reference to the categories of food referred to in article 1 may be made exclusively by persons having qualifications in medicine , nutrition , pharmacy or other professionals responsible for maternal and child health care . ### paragraph 3 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine , nutrition and pharmacy or other professionals responsible for maternal and child health care .


### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food and food for special medical purposes . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children and to food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . ### a limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment ; such categories of food are vital for the management of certain conditions and / or are essential to maintain the intended nutritional adequacy for certain well - established vulnerable groups of the population . those categories of food include infant formulae and follow - on formulae , processed cereal - based food and baby food , milk based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure of intense muscular effort , and foodstuffs for people intolerant to gluten . experience has shown that the provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec , commission regulation no 41 / 2009 , as well as commission directive 96 / 8 / ec ensure the free movement of such food in a satisfactory manner , while ensuring a high level of protection of public health . it is therefore appropriate that this regulation focuses on the general compositional and information requirements for infant formula and follow - on formulae , processed cereal - based food and baby food for infants and young children , milk - based drinks intended for young children , food for special medical purposes , food intended for weight reduction and control , food intended to meet the expenditure of intense muscular effort , and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec commission directive 1999 / 21 / ec , commission directive 96 / 8 / ec and commission regulation no 41 / 2009 . in addition , the concept of ' specialised nutrition ' should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population , which otherwise could not be placed on the market under current union legislation .


### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec and directive 1999 / 21 / ec as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations , no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following : ### subject to the general requirements of articles 7 and 9 and taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec and regulation no 41 / 2009 , as well as any technical and scientific progress , the commission shall be empowered to adopt delegated regulations for foods referred to in article 1 no later than [ 2 years after the date of the entry into force of this regulation ] , in accordance with article 15 , with respect to the following :


### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec and commission directive 1999 / 21 / ec . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### this regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten , taking into account commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , commission directive 1999 / 21 / ec and commission regulation no 41 / 2009 . in order to adapt the definitions of infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and foodstuffs for people intolerant to gluten laid down in this regulation taking into account technical and scientific progress and relevant developments at international level , to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this regulation , including for additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and for the authorisation of nutrition and health claims , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### infant formula and follow - on formula ; ### infant formula and follow - on formula for infants in good health ;


### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in commission regulation no 41 / 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten . such statements could be construed as nutrition claims , as defined in regulation no 1924 / 2006 . for the sake of simplification , those statements should be regulated solely by regulation no 1924 / 2006 and comply with requirements therein . it is necessary that technical adaptations pursuant to regulation no 1924 / 2006 , incorporating the nutrition claims ‘ gluten - free’ and ‘ very low gluten’ and their associated conditions of use as regulated under regulation no 41 / 2009 be completed prior to the entry into application of this regulation . ### currently , the statements ‘ gluten - free’ and ‘ very low gluten’ may be used for foods for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of regulation no 41 / 2009 . in addition , the statement ‘ gluten - free’ may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of regulation no 41 / 2009 which do not allow the use of the statement ‘ very low gluten’ for these foods . such foods for specialized nutrition intended for people intolerant to gluten should be maintained in this regulation , as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease . this is in line with the international standard for foods for special dietary use for persons intolerant to gluten .


### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information and must not be misleading . ### the labelling , presentation and advertising of food referred to in article 1 shall provide adequate consumer information , must not be misleading and must be based on scientific data validated by the authority .


### the systems and their operation shall be secure . ### the systems and their operation shall be secure in view of their implications for the security and defence policy interests of the union and the member states .


### the labels are established in an open and transparent procedure in which all stakeholders , including government bodies , consumers , manufacturers , distributors and environmental organisations may participate , ### the labels are established in an open and transparent procedure in which all stakeholders , including government bodies , consumers , manufacturers , trade unions , distributors and environmental organisations may participate ,


### where the value of a modification can be expressed in monetary terms , the modification shall not be considered to be substantial within the meaning of paragraph 1 , where its value does not exceed the thresholds set out in article 12 and where it is below 5% of the price of the initial contract , provided that the modification does not alter the overall nature of the contract . where several successive modifications are made , the value shall be assessed on the basis of the cumulative value of the successive modifications . ### where the value of a modification can be expressed in monetary terms , the modification shall not be considered to be substantial within the meaning of paragraph 1 , where its value does not exceed the thresholds set out in article 12 and where it is below 15 % of the price of the initial contract , provided that the modification does not alter the overall nature of the contract . where several successive modifications are made , the value shall be assessed on the basis of the cumulative value of the successive modifications .


### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the notice used to make the call for competition , or in the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for example , mention may be made of the requirements applicable during the performance of the contract to recruit long - term job - seekers or to implement training measures for the unemployed or for young persons , to comply in substance with fundamental international labour organisation conventions , even where such conventions have not been implemented in national law , and to recruit more disadvantaged persons than are required under national legislation . ### contract performance conditions are compatible with this directive provided that they are not directly or indirectly discriminatory , are linked to the subject - matter of the contract and are indicated in the notice used to make the call for competition , or in the procurement documents . they may , in particular , be intended to favour on - site vocational training , the employment of people experiencing particular difficulty in achieving integration , the fight against unemployment , protection of the environment or animal welfare . for example , mention may be made of the requirements applicable during the performance of the contract to recruit long - term job - seekers or to implement training measures for the unemployed or for young persons , to comply in substance with the working conditions along the supply chain as stated in national labour laws and regulations in which production processes take place and in international conventions as listed in annex xiv , whatever the most favourable for workers . these provisions include : those defined by the eight ilo core conventions ; occupational safety and health ; working time ; wages and social security .


### compliance , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law or environmental law or of the international social and environmental law provisions listed in annex xiv or , where not applicable , with other provisions ensuring an equivalent level of protection ; ### compliance , at least in an equivalent manner , with obligations established by union legislation in the field of social and labour law or environmental law or , with the obligations regarding working conditions along the supply chain as stated in national labour laws and regulations in which production processes take place and in international conventions as listed in annex xiv , whatever the most favourable of workers . these provisions include : those defined by the eight ilo core conventions ; occupational safety and health working time wages social security


### quality , including technical merit , aesthetic and functional characteristics , accessibility , design for all users , environmental characteristics and innovative character ; ### quality , including technical merit , aesthetic and functional characteristics , accessibility , design for all users , environmental , social characteristics and innovative character ;


### member states shall submit to the commission the existing inter - governmental agreements concluded with third countries which have an impact on the development of gas infrastructures and supplies ; before concluding new inter - governmental agreements , the member states shall inform the commission to assess their compliance with the internal market legislation ; ### member states shall submit to the commission the existing inter - governmental agreements concluded with third countries which have an impact on the development of gas infrastructures and supplies ;


### turning waste into a resource , as called for in the resource efficiency roadmap , requires the full implementation of eu waste legislation across the eu , based on strict application of the waste hierarchy and covering different types of waste . additional efforts are needed to : reduce per capita waste generation in absolute terms , limit energy recovery to non - recyclable materials , phase out landfilling , ensure high quality recycling , and develop markets for secondary raw materials . hazardous waste will need to be managed so as to minimise significant adverse effects on human health and the environment , as agreed at the rio + 20 summit . to achieve this , market - based instruments that privilege prevention , recycling and re - use should be applied much more systematically across the eu . barriers facing recycling activities in the eu internal market should be removed and existing prevention , re - use , recycling , recovery and landfill diversion targets reviewed so as to move towards a ‘ circular’ economy , with a cascading use of resources and residual waste close to zero . ### turning waste into a resource , as called for in the resource efficiency roadmap , requires the full implementation of eu waste legislation across the eu , based on strict application of the waste hierarchy and covering different types of waste . additional efforts are needed to : reduce national waste generation in relation to gnp , ensure high quality recycling , and develop markets for secondary raw materials . hazardous waste will need to be managed so as to minimise significant adverse effects on human health and the environment , as agreed at the rio + 20 summit . to achieve this , market - based instruments that privilege prevention , recycling and re - use should be applied much more systematically across the eu . barriers facing recycling activities in the eu internal market should be removed and existing prevention , re - use , recycling , recovery and landfill diversion targets reviewed so as to move towards a ‘ circular’ economy , with a cascading use of resources and residual waste close to zero .


### since 80% of all product - related environmental impacts are locked in during their design phase , the eu policy framework should ensure that priority products placed on the eu market are ‘ eco - designed’ with a view to optimising resource and material efficiency , by addressing inter alia recyclability , recycled content and durability . these requirements will have to be implementable and enforceable . efforts will be stepped up at eu and national level to remove barriers to eco - innovation and to unlock the full potential of europe’s eco - industries , generating benefits for green jobs and growth . ### since 80% of all product - related environmental impacts are locked in during their design phase , the eu policy framework should act as an incentive for priority products placed on the eu market to be ‘ eco - designed’ with a view to optimising resource and material efficiency , by addressing inter alia recyclability , recycled content and durability . these requirements will have to be implementable and enforceable . efforts will be stepped up at eu and national level to remove barriers to eco - innovation and to unlock the full potential of europe’s eco - industries , generating benefits for green jobs and growth .


### waste is safely managed as a resource , waste generated per capita is in absolute decline , energy recovery is limited to non - recyclable materials and landfilling of recyclable and compostable materials is effectively eradicated . ### waste is safely managed as a resource and in such a way as to prevent any harm being caused to the environment and to health , waste generated in relation to gnp is in decline and recyclable and compostable waste is gradually being shifted away from disposal streams and into recycling and recovery streams .


### fully implementing the climate and energy package and agreeing on the eu ' s climate and energy policy framework for the period beyond 2020 . ### freezing the implementation of the climate and energy package , with the exception of energy efficiency standards , until , internationally , a new legally binding global agreement has been signed , with a view to reducing ghg emissions by 80 - 95% by 2050 compared to 1990 , as part of a global effort to limit average temperature increase to below 2&#176 ; c .


### all sectors of the economy will need to contribute to reducing ghg emissions for the eu to deliver its fair share of global efforts . the eu needs to agree the next steps for its climate and energy framework beyond 2020 in order to prepare itself for international negotiations on a new legally binding agreement , but also to provide member states and industry with a clear framework to make the medium - term investments needed . hence the eu needs to consider policy options for delivering the reductions set out in the low - carbon economy roadmap for the period beyond 2020 . the 2050 energy roadmap and the white paper on transport need to be underpinned by strong policy frameworks . moreover , member states need to develop and put in place long - term , cost - effective low - carbon development strategies aimed at achieving the eu objective of reducing ghg emissions by 80% to 95% by mid - century , compared to 1990 , as part of a global effort to limit average temperature increase to below 2°c . the eu emissions trading system will continue to be a central pillar of eu climate policy beyond 2020 . ### all sectors of the economy will need to contribute to reducing ghg emissions for the eu to deliver its fair share of global efforts . the eu needs to agree the next steps to prepare itself for international negotiations on a new legally binding global agreement , with the aim of providing member states and industry with a clear framework to make the medium - and long - term investments needed . the 2050 energy roadmap and the white paper on transport need to be underpinned by strong policy frameworks . moreover , member states need to develop and put in place long - term , cost - effective , low - carbon development strategies aimed at achieving the eu objective of reducing ghg emissions by 80% to 95% by mid - century , compared to 1990 , as part of a global effort to limit average temperature increase to below 2°c . the eu emissions trading system will probably continue to be one of the key instruments of eu climate policy beyond 2020 .


### the time span covered by this programme corresponds to key phases in international climate , biodiversity and chemical policy . to remain within the 2 °c ceiling , global ghg emissions need to be cut by at least 50 % of their 1990 levels by 2050 . however , only half the emission reductions required by 2020 have been pledged by parties under the unfccc . without more resolute global action , climate change is unlikely to be curtailed . even in a best - case scenario , countries will increasingly face inevitable impacts of climate change because of historical ghg emissions and will need to develop climate adaptation strategies . under the durban platform for enhanced action , a comprehensive and robust agreement applicable to all is to be agreed by 2015 and implemented as of 2020 . the eu will remain engaged proactively in this process , including in discussions on how to close the gap between current emission reduction pledges by developed and developing countries , and on action needed to stay on an emission pathway compatible with the 2oc objective . the follow - up to rio + 20 should also help reduce ghg emissions , thus supporting the fight against climate change . in parallel , the eu should pursue and further intensify climate change partnerships with strategic partners and should take further action to mainstream environment and climate considerations in its development policy . ### the time span covered by this programme corresponds to key phases in international climate , biodiversity and chemical policy . according to the ipcc , to remain within the 2 °c ceiling , global ghg emissions need to be cut by at least 50 % of their 1990 levels by 2050 . however , only half the emission reductions required by 2020 have been pledged by parties under the unfccc . without more resolute global action , climate change is unlikely to be mitigated . even in a best - case scenario , countries will increasingly face inevitable impacts of climate change and will need to develop climate adaptation strategies . under the durban platform for enhanced action , a comprehensive and robust agreement applicable to all is to be agreed by 2015 and implemented as of 2020 . the eu will remain engaged proactively in this process , including in discussions on how to close the gap between current emission reduction pledges by developed and developing countries , and on action needed to stay on an emission pathway compatible with the 2oc objective . the follow - up to rio + 20 should also help reduce ghg emissions , thus supporting the adaptation to climate change . in parallel , the eu should pursue and further intensify climate change partnerships with strategic partners and should take further action to mainstream environment and climate considerations in its external policy on the basis of reciprocity and conditionality .


### fully implementing the eu climate and energy package is essential to reach the milestones identified for 2020 and for building a competitive , low - carbon economy by 2050 . whereas the eu is currently on track to reduce domestic ghg emissions 20 % below 1990 levels by 2020 , meeting the 20 % energy efficiency target will require far more rapid efficiency improvements . this is also important in the light of still - growing demand for energy and the on - going debate on conflicts between land use for food and for bio - energy . the new energy efficiency directive is expected to make a significant contribution in this regard . ### fully implementing the eu climate and energy package is considered to be essential for reaching the milestones identified for 2020 and meeting the objectives for 2050 . whereas the eu is currently on track to reduce domestic ghg emissions 20 % below 1990 levels by 2020 , it is regrettable to note that the implementation of the package is causing an unsustainable increase in the cost of energy and is paradoxically encouraging carbon leakage . it is hoped that the new energy efficiency directive will significantly remedy this problem . as regards the efficient and sustainable use of resources , account should be taken in particular of the ongoing debate on conflicts between land use for food and for biofuels .


### the union and member states will need to put in place the right conditions to ensure that environmental externalities are adequately addressed and that the right market signals are sent to the private sector , with due regard to any adverse social impacts . this will involve applying the polluter - pays principle more systematically , through phasing out environmentally harmful subsidies and shifting taxation away from labour towards pollution . as natural resources become increasingly scarce , the economic rent and profits associated with their ownership or exclusive use may increase . public intervention to ensure that such rents are not excessive and that externalities are taken into account will lead to more efficient use of these resources and will help to avoid market distortions , as well as generate public revenue . environment and climate priorities will be pursued in the framework of the european semester where these are relevant to the sustainable growth prospects of individual member states to which country - specific recommendations are addressed . other market - based instruments , such as payments for ecosystem services , should be used more extensively at eu and national level to incentivise private sector involvement and sustainable management of natural capital . ### the union and member states will need to put in place the right conditions to ensure that environmental externalities are adequately addressed and that the right market signals are sent to the private sector , with due regard to any adverse social impacts . this will involve applying the polluter - pays principle more systematically , through phasing out environmentally harmful subsidies . as natural resources become increasingly scarce , the economic rent and profits associated with their ownership or exclusive use may increase . public intervention to ensure that such rents are not excessive and that externalities are taken into account will lead to more efficient use of these resources and will help to avoid market distortions , as well as generate public revenue . environment and climate priorities will be pursued in the framework of the european semester where these are relevant to the sustainable growth prospects of individual member states to which country - specific recommendations are addressed . at eu and national level , private sector involvement and sustainable management of natural capital should be incentivised .


### the europe 2020 strategy’s ‘ resource - efficient europe’ flagship initiative aims to support the shift towards an economy that is efficient in the way it uses all resources , decouples absolutely economic growth from resource and energy use and its environmental impacts , reduces ghg emissions , enhances competitiveness through efficiency and innovation and promotes greater energy security . the roadmap to resource efficient europe43 and the roadmap for moving to a competitive low - carbon economy44 are key building blocks of the initiative , setting out the framework for future actions to deliver on these objectives . ### the europe 2020 strategy’s ‘ resource - efficient europe’ flagship initiative aims to make competitive an economy that is efficient in the way it uses all resources , decouples , as far as possible , economic growth from resource and energy use and its environmental impacts , reduces ghg emissions , aims at innovation and promotes greater energy security . the roadmap to resource efficient europe and the roadmap for moving to a competitive low - carbon economy are key building blocks of the initiative , since they take some of the various possible scenarios as benchmarks for future actions to deliver on these objectives .


### 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 solidarity , intercommunication and social , economic , political and cultural inclusion 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 , discrimination , ignorance , illiteracy , gender inequalities or digital or innovation divides , in european societies and other world regions .


### the agency should act in the interest of the union . this should include that the agency may act outside the territory of the eu in its fields of competence . ### the agency should act in the interest of the union . this should include that the agency may act outside the territory of the eu in its fields of competence . in addition it should actively contribute to the establishment of a european maritime transport policy in a common maritime transport space .


### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport and the marine environment . the use of the agency ' s response capabilities should be explicitly extended to cover response to pollution originating from such activities . in addition , the agency should assist the commission in analysing the safety of mobile offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and response to marine pollution . ### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport and the marine environment . the use of the agency ' s response capabilities should be explicitly extended to cover response to pollution originating from such activities . in addition , the agency should , within the limits of its remit , assist the commission in analysing , inside and outside the territory of the union , the safety of mobile offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and response to marine pollution .


### those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of gmos ; and ### deleted


### one of the objectives of this regulation is to remove existing barriers to the cross - border use of electronic identification means used in the member states to access at least public services . this regulation does not aim at intervening on electronic identity management systems and related infrastructures established in the member states . the aim of this regulation is to ensure that for the access to cross - border online services offered by the member states , secure electronic identification and authentication is possible . ### one of the objectives of this regulation is to remove existing barriers to the cross - border use of electronic identification means used in the member states to access at least public services . this regulation does not aim at intervening on electronic identity management systems and related infrastructures established in the member states . the aim of this regulation is to ensure that for the access to cross - border online services offered by the member states , a high degree of security can be provided for electronic identification and authentication , for instance by establishing security levels adjusted according to the types of services to be accessed .


### this regulation lays down rules for electronic identification and electronic trust services for electronic transactions with a view to ensuring the proper functioning of the internal market . ### this regulation lays down rules for electronic identification and trust services for electronic transactions with a view to ensuring the proper functioning of the internal market , guaranteeing a high level of security for identification means and trust services and boosting public trust in the digital world .


### coordination ### coordination and interoperability


### member states shall cooperate in order to ensure the interoperability of electronic identification means falling under a notified scheme and to enhance their security . ### member states shall cooperate in order to ensure the interoperability and technological neutrality of electronic identification means falling under a notified scheme and to enhance their security .


### mutual recognition and acceptance ### mutual recognition


### if no opinion is delivered , the commission may adopt the draft measures . where the commission does not adopt the draft measures , the chairperson may submit to the committee an amended version of the draft measures . ### if no opinion is delivered , the commission may not adopt the draft measures .


### the commission shall ensure that the quantity of hydrofluorocarbons that producers and importers are entitled to place on the market in the union each year does not exceed the maximum quantity for the year in question calculated in accordance with annex v . each producer and importer shall ensure that the quantity of hydrofluorocarbons calculated in accordance with annex v that it places on the market does not exceed the quota allocated to it pursuant to article 14 or transferred to it pursuant to article 16 . ### the commission shall ensure that the quantity of hydrofluorocarbons as listed in annexes i and ii that producers and importers of hydrofluorocarbons or products containing hydrofluorocarbons are entitled to place on the market in the union each year does not exceed the maximum quantity for the year in question calculated in accordance with annex v . each producer and importer of hydrofluorocarbons or products containing hydrofluorocarbons shall ensure that the quantity of hydrofluorocarbons calculated in accordance with annex v that it places on the market does not exceed the quota allocated to it pursuant to article 14 or transferred to it pursuant to article 16 .


### the characteristics required of a product including levels of quality , performance , interoperability , safety or dimensions , including the requirements applicable to the product as regards the name under which the product is sold , terminology , symbols , testing and test methods , packaging , marking or labelling and conformity assessment procedures ; ### the characteristics required of a product including levels of quality , performance , interoperability , environmental protection , health , safety or dimensions , including the requirements applicable to the product as regards the name under which the product is sold , terminology , symbols , testing and test methods , packaging , marking or labelling and conformity assessment procedures ;


### recognition of technical specifications in the field of ict ### recognition and use of technical specifications in the field of ict


### each european and national standardisation body shall send any draft national standard , european standard and european standardisation deliverable to other european and national standardisation bodies and the commission , upon their request . ### each european and national standardisation body shall systematically send any draft national standard , european standard and european standardisation deliverable to other european and national standardisation bodies and the commission . each draft national standard shall be sent in english additionally to the national language .


### to improve the level of key competences and skills regarding in particular their relevance for the labour market and society , as well as the participation of young people in democratic life in europe , notably through increased learning mobility opportunities for young people , learners , staff and youth workers , and through strengthened cooperation between education youth and the world of labour market ; ### to improve the level of key competences and skills regarding in particular the labour market and society , as well as the participation of young people in democratic life in europe , notably through increased mobility opportunities for young people resulting from strengthened cooperation between education youth and the world of labour market ;


### to enhance the international dimension of education , training and youth notably in higher education by increasing the attractiveness of the union higher education institutions and supporting the union external action , including its development objectives through the promotion of mobility and cooperation between eu and third country higher education institutions and targeted capacity building in third countries . ### to enhance the international dimension of education and training , notably through cooperation between union and third country institutions in the field of vet and in higher education .


### the programme should include a strong international dimension particularly as regards higher education , not only to enhance the quality of european higher education in pursuit of the broader et2020 objectives and the attractiveness of the union as a study destination , but also to promote understanding between people and contribution to the sustainable development of higher education in the third countries . ### the programme should include a strong international dimension particularly as regards higher education , not only to enhance the quality of european higher education in pursuit of the broader et2020 objectives and the attractiveness of the union as a study and research destination , but also to promote understanding between people and contribution to the sustainable development of higher education in the third countries . in this connection , attention is drawn to the europe 2020 target of investing at least 3% of gdp in research and innovation .


### ‘ corrective action’ means action taken to eliminate the cause of a potential or real non - conformity or other undesirable situation ; ### ‘ corrective action’ means action to eliminate the cause of non - conformities in order to prevent recurrence ;


### ‘ field safety notice’ means the communication sent by the manufacturer to users or customers in relation to a field safety corrective action ; ### ‘ field safety notice’ : a communication sent out by a manufacturer or its representative to the device users in relation to a field safety corrective action ;


### ‘ field safety corrective action’ means corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market ; ### field safety corrective action : a field safety corrective action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device ;


### ‘ field safety notice’ means the communication sent by the manufacturer to users or customers in relation to a field safety corrective action ; ### ‘ field safety notice’ means a communication sent out by a manufacturer or its representative to the device users in relation to a field safety corrective action ;


### the commission shall be empowered to adopt delegated acts in accordance with article 68 for the purpose of adapting the list of related financial audit services referred to in paragraph 2 and the list of non - audit services referred to in paragraph 3 of this article . when using such powers , the commission shall take into account developments in auditing and the audit profession . ### member states may exceptionally add to the list of services prohibited by virtue of paragraph 3 , for statutory auditors or audit firms for which the relevant member state is the home member state , provided such additions result from existing requirements under national law or regulation .


### member states shall ensure that statutory auditors and audit firms comply with international auditing standards when carrying out statutory audits as long as those standards are in conformity with the requirements of this directive and of regulation xx / xx . ### member states may require that statutory auditors and audit firms comply with international auditing standards when carrying out statutory audits .


### ' collecting society ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ; ### ' collective management organisation ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by a substantial number of rightholders , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ;


### the statute of the collecting society shall provide for appropriate and effective mechanisms of participation of its members in the collecting society ' s decision - making process . the representation of the different categories of members in the decision - making process shall be fair and balanced . ### the statute of the collecting society shall provide for appropriate and effective mechanisms of participation of its members in the collecting society ' s decision - making process . the representation of the different categories of members at all levels of the decision - making process shall be fair and balanced .


### every member of a collecting society shall have the right to appoint any other natural or legal person as a proxy holder to attend and vote at the general meeting in his name . ### every member of a collecting society shall have the right to appoint any other natural or legal person that is a member of that collecting society as a proxy holder to attend and vote at the general meeting in his name . when a collective management organisation represents more than one category of right holders , a member may only give a proxy to another member from the same category . the number of proxies that may be held by a single member shall be capped .


### this directive lays down requirements necessary to ensure the proper functioning of the management of copyright and related rights by collecting societies . it also lays down requirements for multi - territorial licensing by collecting societies of authors ' rights in musical works for online use . ### this directive lays down requirements necessary to ensure the proper functioning of the management of copyright and related rights by collective management organisations . it also lays down requirements for multi - territorial licensing by collecting societies of authors ' rights in musical works for online use .


### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no 1760 / 2000 , no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply . ### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply .


### where the commission has adopted a delegated act in accordance with article&#160 ; 308b , article&#160 ; 35 shall not apply for a maximum period of five years from the date referred to in the first sub - paragraph of article 309 . ### where the commission has adopted a delegated act in accordance with article&#160 ; 308b , article&#160 ; 35 shall not apply for a maximum period of three years from the date referred to in the first sub - paragraph of article&#160 ; 309 .


### actions to promote mobility of individuals in the union , in particular the development of a multilingual digital platform for the clearance of job vacancies and applications , and targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or to help specific groups of workers such as young people . ### actions to promote mobility of individuals in the union , in particular the development of a multilingual digital platform for the clearance of job vacancies and applications , and targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or to help specific groups of workers such as young people , in the awareness that the promotion of geographical mobility among young people should not facilitate trends such as ' brain drains ' from member states that are having greater difficulty to the more prosperous member states . such brain drains could undermine the ability of the member states in difficulty to overcome the crisis ; geographical mobility must not , therefore , become the only option available to young people , but should complement the increase in work opportunities in the member state of origin of those same young people .


### unless the debtor is not responsible for the delay , the creditor shall , in addition to the amounts set out in paragraph 1 , be entitled to obtain reasonable compensation from the debtor for all remaining recovery costs incurred through the latter ' s late payment . ### except where the debtor is exempted from responsibility for the delay , the creditor shall , in addition to the amounts set out in paragraph 1 , be entitled to obtain reasonable compensation from the debtor for all remaining recovery costs incurred through the latter ' s late payment .


### the union may enter into agreements with third countries and international organisations in the context of the programmes , in particular , cooperation agreements in accordance with the procedure laid down in article 218 of the treaty on the functioning of the european union . ### the union may enter into agreements with third countries and international organisations in the context of the programmes , in particular , cooperation agreements in accordance with the procedure laid down in article 218 of the treaty on the functioning of the european union . any form of cooperation with third countries shall take account of the strategic nature of the programmes , be in accordance with the security and defence policy interests of the union and the member states and respect the principle of mutuality .


### the aim of the galileo programme is to establish and operate the first global satellite navigation and positioning infrastructure specifically designed for civilian purposes . the system established under the galileo programme is completely independent of other existing or potential systems . ### the aim of the galileo programme is to establish and operate the first global satellite navigation and positioning infrastructure specifically designed for civilian purposes . given its dual use nature , member states should be able to exercise their right to use the programme also for security and defence purposes . furthermore , the union should be able to exploit its full potential for the union ' s csdp missions and operations . the system established under the galileo programme is completely independent of other existing or potential systems , thus contributing to the strategic independence and autonomy of the union , as emphasised in 2007 by the european parliament and the council .


### cross - border distance sales of tobacco products ; ### the prohibition of cross - border distance sales of tobacco products ;


### define the position , format , layout , design , rotation and proportions of the health warnings ; ### define the layout , design and rotation of the health warnings ;


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


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


### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes . taking into account internationally agreed standards , where available , and based on scientific evidence and on the yields notified by member states , the commission shall be empowered to adopt delegated acts in accordance with article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar , nicotine and carbon monoxide fixed in paragraph 1 . ### member states shall notify the commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes .


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 4 , 6 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 14 , 18 and 18 shall be conferred on the commission for a period of five years from [ office of publications : please insert the date of the entry into force of this directive ] .


### in order to ensure uniform conditions for the implementation of this directive , in particular concerning the format of ingredients reporting , the determination of products with characterising flavours or with increased levels of toxicity and addictiveness and the methodology for determining whether a tobacco product has characterising flavour , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 . ### in order to ensure uniform conditions for the implementation of this directive , in particular concerning the format of ingredients reporting and the determination of products with characterising flavours or with increased levels of toxicity and addictiveness , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation no 182 / 2011 .


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the design characteristics of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed .


### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 4 , 6 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 5 years following the date referred to in paragraph 1 of article 25 . ### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 10 years following the date referred to in paragraph 1 of article 25 .


### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 4 , 6 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### ‘ maximum level’ or ‘ maximum yield’ means the maximum content or emission , including 0 , of a substance in a tobacco product measured in grams ; ### ' maximum level ' or ' maximum yield ' means the maximum content or emission of a substance in a tobacco product measured in grams ;


### the prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether , but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour . the use of additives necessary for manufacturing of tobacco products should be allowed , as long as they do not result in a characterising flavour . the commission should ensure uniform conditions for the implementation of the provision on characterising flavour . independent panels should be used by the member states and by the commission to assist in such decision making . the application of this directive should not discriminate between different tobacco varieties . ### the prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether , but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour . the use of additives which are essential for the manufacture of tobacco products should be allowed , as long as they do not result in a characterising flavour . the commission should ensure uniform conditions for the implementation of the provision on characterising flavour . independent panels should be used by the member states and by the commission to assist in such decision making . the application of this directive should not discriminate between different tobacco varieties .


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


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 18 and 18 shall be conferred on the commission for a period of [ five ] years from [ office of publications : please insert the date of the entry into force of this directive ] .


### the revised annex vi to marpol introduces , inter alia , stricter sulphur limits for marine fuel in secas as well as in sea areas outside secas . most member states are obliged to require ships to use fuel with maximum 1 . 00% sulphur content in secas as of 1 july 2010 based on their international commitments . in order to ensure coherence with international law as well as to secure proper enforcement of new globally established sulphur standards in the union , the provisions of directive 1999 / 32 / ec should be aligned with the revised annex vi to marpol . in order to ensure a minimum quality of fuel used by ships either for fuel or technology based compliance , marine fuel the sulphur content of which exceeds the general standard of 3 . 5 % by mass should not be allowed for use or placing on the market in the union . ### the revised annex vi to marpol introduces , inter alia , stricter sulphur limits for marine fuel in secas as well as in sea areas outside secas . most member states are obliged to require ships to use fuel with maximum 1 . 00% sulphur content in secas as of 1 july 2010 under their international commitments . in order to ensure a minimum quality of fuel used by ships either for fuel - or technology - based compliance , marine fuel the sulphur content of which exceeds the general standard of 3 . 5 % by mass should not be allowed for use or placing on the market in the union .


### ‘ unavoidable and extraordinary circumstances’ means a situation beyond the control of the trader the consequences of which could not have been avoided even if all reasonable measures had been taken ; ### ' unavoidable and extraordinary circumstances ' means unusual and unforeseeable circumstances beyond the control of the party by whom it is pleaded , the consequences of which could not have been avoided even if all due care had been exercised ;


### if a member state has doubts about the insolvency protection of an organiser or of a retailer facilitating the procurement of assisted travel arrangements which is established in a different member state and is operating on its territory , it shall seek clarification from the member state of establishment . member states shall respond to requests from other member states at the latest within 15 working days of receiving them . ### if a member state has doubts about the insolvency protection of an organiser which is established in a different member state and is operating on its territory , it shall seek clarification from the member state of establishment . member states shall respond to requests from other member states at the latest within 15 working days of receiving them .