### ‘ population control’ means physical , chemical or biological actions applied to a population of invasive alien species with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised . ### ‘ population control’ means lethal or non - lethal physical , chemical or biological actions applied to a population of invasive alien species , while also avoiding impact on non - targeted species and their habitats , with the aim of keeping the number of individuals as low as possible , so that , while not being able to eradicate the species , its invasive capacity and adverse impacts on biodiversity and ecosystem services , or on human health and the economy , are minimised .


### for non - commercial owners who cannot ensure that the conditions set out in paragraph 1 are met , member states shall offer to them the possibility of having their specimens taken over from them and shall give due regard to animal welfare when handling them . ### for non - commercial owners who cannot comply with the requirements in paragraph 1 , member states must remove the animals , ensuring that they are spared any avoidable pain , distress or suffering .


### ‘ invasive alien species of union concern’ means invasive alien species whose negative impact has been deemed such as to require concerted action at the level of the union pursuant to article 4 ; ### ‘ invasive alien species of union concern’ means invasive alien species which are alien to the territory of the union excluding the outermost regions , or alien to one biogeographical region of the union but native to another , whose negative impact has been deemed such as to require concerted action at the level of the union pursuant to article 4 .


### the delegation of power referred to in article 5 shall be conferred on the commission for an undetermined period of time from the entry into force of this regulation . ### the delegation of power referred to in article 5 shall be conferred on the commission for a period of five years from [ the date of entry into force of this regulation ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the distribution of the invasive alien species of union concern present in their territory ; ### the distribution of the invasive alien species of union concern present in their territory and marine waters including information regarding migratory or reproductive patterns ;


### the action plan referred to in paragraph 2 shall include measures designed on the basis of an analysis of costs and benefits with at least the following : ### the action plan referred to in paragraph 2 shall include , but not be limited to , measures , including as appropriate , regulatory or voluntary actions and codes of good practice to :


### a description of the current distribution of the species including whether the species is already present in the union or in neighbouring countries ; ### a description of the current distribution of the species including whether the species is already present in the union as a native or alien species or in neighbouring countries ;


### they are , having regard to scientific evidence available , found to be alien to the territory of the union excluding the outermost regions ; ### they are found , based on available scientific evidence , to be alien to the territory of the union excluding the outermost regions , or alien to one biogeographical region of the union but native to another ;


### by way of derogation from to article 7 and , owners of companion animals not kept for commercial purposes that belong to the species included on the list referred to in article 4 shall be allowed to keep them until the end of the animals ' natural life , provided the following conditions are met : ### by way of derogation from to article 7 and , owners of pet animals not kept for commercial purposes that belong to the species included on the list referred to in article 4 shall be allowed to keep them until the end of the animals ' natural life , provided the following conditions are met :


### the name of the species ; ### the name of the species or taxonomic group of species ;


### the power to adopt delegated acts referred to in articles 8 , 13 , 15 , 16 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 29 , 30 , 31 , 35 and 37 shall be conferred on the commission for an indeterminate period of time from the entry into force of this regulation . ### the power to adopt delegated acts referred to in articles 15 , 16 , 21 , 23 , 25 , 27 , 29 , 30 , 31 , 35 and 37 shall be conferred on the commission for an indeterminate period of time from the entry into force of this regulation .


### the commission shall be empowered to adopt delegated acts , in accordance with article 38 , concerning the definition of procedures applicable to the tasks referred to in paragraph 2 . ### the commission shall be empowered to adopt implementing acts , in accordance with article 39 , concerning the definition of procedures applicable to the tasks referred to in paragraph 2 .


### a trust service provider shall be liable for any direct damage caused to any natural or legal person due to failure to comply with the obligations laid down in article 15 , unless the trust service provider can prove that he has not acted negligently . ### a trust service provider shall be liable for any damage caused to any natural or legal person due to non - compliance with the obligations laid down in article 15 , unless the trust service provider can prove that he has not acted negligently .


### the commission may , by means of implementing acts , establish reference numbers of standards for the security assurance levels of electronic seals . compliance with the security assurance level defined in a delegated act adopted pursuant to paragraph 6 shall be presumed when an electronic seal meets those standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union . ### the commission shall , by means of implementing acts , establish reference numbers of standards for the defined security levels of electronic seals . compliance with the defined security level in annex iii shall be presumed when an electronic seal meets those standards . the implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . the commission shall publish those acts in the official journal of the european union .


### member states shall notify to the commission , without undue delay , information on the body responsible for establishing , maintaining and publishing national trusted lists , and details of where such lists are published , the certificate used to sign or seal the trusted lists and any changes thereto . ### member states shall notify to the commission , without undue delay , information on the body responsible for establishing , maintaining and publishing national trusted lists , and details of where such lists are published , the certificate that is used to validate the signature or seal applied to the trusted lists and any changes thereto .


### to enable the commission and the member states to assess the effectiveness of the breach notification mechanism introduced by this regulation , supervisory bodies should be requested to provide summary information to the commission and to european network and information security agency . ### to enable the commission and the member states to assess the effectiveness of the breach notification mechanism introduced by this regulation , supervisory bodies should be requested to provide summary information to european network and information security agency .


### the commission shall , where appropriate , adapt the timetable for each period so as to ensure an orderly functioning of the market . ### the commission may , in exceptional circumstances , adapt the timetable for the period referred to in article 13 beginning on 1 january 2013 so as to ensure an orderly functioning of the market . the commission shall make no more than one such adaptation .


### by way of derogation from article 94 of regulation no [ &#8230 ; ] [ rd ] , for the measures of article 36 to and and of regulation no 1698 / 2005 , member states may continue to undertake new legal commitments to beneficiaries in 2014 pursuant to the rural development programmes adopted on the basis of regulation no 1698 / 2005 even after the financial resources of the 2007 - 2013 programming period have been used up , until the adoption of the respective rural development programme for the 2014 - 2020 programming period . the expenditure incurred on the basis of these commitments shall be eligible in accordance with article 3 of this regulation . ### by way of derogation from article 94 of regulation no [ &#8230 ; ] [ rd ] , member states may continue to undertake new legal commitments to beneficiaries in 2014 , in relation to the measures referred to in articles 20 , 36 , 52 and 63 of regulation no 1698 / 2005 , pursuant to the rural development programmes adopted on the basis of regulation no 1698 / 2005 even after the financial resources of the 2007 - 2013 programming period have been used up , until the adoption of the respective rural development programme for the 2014 - 2020 programming period , or until the end of 2014 . the expenditure incurred on the basis of these commitments shall be eligible in accordance with article 3 of this regulation .


### in the initial period , the eit has mainly focused its efforts on establishing the kics . while it is a clear goal for the eit to strengthen existing centres of excellence , the eit will need to ensure it also delivers benefits to areas of the union which are not directly participating in kics . it is therefore mission critical for the eit to actively promote the dissemination of good practices for the integration of the knowledge triangle in order to develop a common innovation and knowledge sharing culture . ### in the initial period , the eit has mainly focused its efforts on establishing the kics . it must be a clear goal for the eit to strengthen existing centres of excellence with a balanced participation of member states . the eit will need to ensure that it also delivers benefits to areas of the union which are not directly participating in kics . it is therefore mission critical for the eit to actively promote the dissemination of good practices for the integration of the knowledge triangle in order to develop a common innovation and knowledge sharing culture .


### prior to initiating the collection of statements of support from signatories , the organiser shall ensure that the online collection system used for that purpose complies with the provisions of paragraph 4 . the organiser may , at any time , ask the relevant competent authority of the member state in which the data collected is or will be stored , to certify that the online collection system complies with those provisions . the organiser shall , in any case , request that certification prior to submitting statements of support for verification in accordance with article 9 . ### prior to initiating the collection of statements of support from signatories , the organisers shall ensure that the online collection system used for that purpose complies with the provisions of paragraph 4 . the organisers may , at any time , ask the relevant competent authority of the member state in which the data collected is or will be stored , to certify that the online collection system complies with those provisions . the organisers shall , in any case , request that certification prior to starting the collection of statements of support . the organiser shall make a copy of the certificate issued in that regard publicly available on the website used for the online collection system . within six months following the entry into force of this regulation , the commission shall make available an open - source software incorporating some of the technical and security features necessary for compliance with the provisions of this regulation regarding the online collection systems . the software shall be freely made available to organisers .


### ' organiser ' means a natural or legal person or organisation responsible for the preparation and submission of a citizens’ initiative to the commission . ### ' organisers ' means natural persons forming a citizens ' committee responsible for the preparation and submission of a citizens’ initiative to the commission .


### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , it is appropriate to clarify that the organiser of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subject to access to his / her personal data as well as the correction and erasure of his / her personal data . ### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , for the sake of legal certainty , it is appropriate to clarify that the organisers of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subjects to have access to their personal data as well as to procure the correction and erasure of their personal data .


### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens ; proposals that are abusive or devoid of seriousness should not be registered and the commission should reject the registration of proposals which would be manifestly against the values of the union . the commission should deal with registration in accordance with the general principles of good administration . ### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives and to avoid a situation in which signatures are collected for a proposal which does not fall within the scope of this regulation , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens . proposals that are not citizens ' initiatives within the meaning of this regulation should not be registered . registration is an administrative procedure aimed at selecting those initiatives that fall within the scope of this regulation ; therefore any refusal of registration should be based only on legal grounds and not , on any account , on grounds of political expediency . the commission should deal with registration in accordance with the general principles of good administration , and should therefore be obliged to inform the organisers of an initiative of the reasons for any refusal to register that initiative and of all possible judicial and extrajudicial remedies available to them . it should also be made clear by the commission that registration and the collection of the required number of statements of support will not necessarily result in the commission adopting a proposal for a legal act and that the registration of an initiative does not constitute a formal decision on competence issues .


### the organiser shall destroy all statements of support received for a given citizens ' initiative and any copies thereof at the latest one month after submitting that initiative to the commission in accordance with article 10 or 18 months after the date of registration of a proposed citizens ' initiative , whichever is the earlier . ### unless the proceedings are the subject of litigation , the organiser shall destroy all statements of support received for a given citizens ' initiative and any copies thereof at the latest two months after the publication of the commission communication referred to in point of article 11 . in the event of litigation , they shall be destroyed one month after the conclusion of the litigation . save where the competent authorities of member states have not yet concluded their verification of statements of support , they shall also be destroyed if a proposed citizens ' initiative has not been submitted to the commission within 18 months after the date of its registration .


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


### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the first day of the month following its publication in the official journal of the european union . it shall start to apply six months after its entry into force .


### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union for the purpose of amending the annexes to this regulation . ### with a view to the possible need in the future to amend or supplement certain non - essential elements in the provisions of this regulation or its annexes , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union .


### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems . ### in order to put modern technology to good use as a tool of participatory democracy , it is appropriate to provide for statements of support to be collected online as well as in paper form . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person signs only once and that the data are securely stored . the detailed technical specifications should be worked out at an expert level and be regularly adapted to technical developments ; the power to adopt detailed technical specifications for online collection systems should therefore be delegated to the commission .


### except in the cases foreseen in paragraphs 3 and 4 , the commission shall register without delay the proposed initiative under a unique registration number and send a confirmation to the organiser . ### if it is established that the proposed initiative qualifies as a citizens ' initiative pursuant to this regulation , the commission shall register it under a unique registration number and send a confirmation to the organisers .


### the commission should examine a citizens ' initiative and set out its conclusions and the actions it envisages to take in response to it , within a period of four months . ### the commission should examine a citizens ' initiative and respond to it in a clear , comprehensible and detailed manner and within a time frame corresponding to its handling of legislative initiatives of the european parliament under article 225 of the treaty on the functioning of the european union . thus , as a first step , the commission should after three months inform the organisers of a successful initiative how it intends to act on the initiative . as a second step , citizens should have the assurance that a successful citizens ' initiative will be the subject of an official public hearing at european union level . the commission , as the addressee of an initiative , should ensure that such a hearing takes place and that it will be represented at an appropriate level . the european parliament , through its committee responsible , should always be invited to participate in the organising of such hearings . as a third step , the commission should come forward with its final response to the initiative , either by proposing legislation accordingly or by explaining in a detailed manner its reasons for not acting on the initiative . the commission should also give a thorough explanation in the event that the legislative proposal diverges significantly from the citizens ' initiative . the decision should be subject to appeal to the court of justice , and / or to the european ombudsman if there appear to be justifiable grounds on which a case of maladministration can be made .


### requirements for the organiser and for signatories ### requirements for organisers and for signatories


### in one third of member states , signatories shall comprise at least the minimum number of citizens set out in annex i . ### in one fifth of member states , signatories shall comprise at least the minimum number of citizens set out in annex i .


### the signatories of a citizens ' initiative shall come from at least one third of member states . ### the signatories of a citizens ' initiative shall come from at least one fifth of member states .


### in order to be eligible to support a proposed citizens ' initiative , signatories shall be citizens of the union and shall be of the age to be entitled to vote in the european elections . ### in order to be eligible to support a proposed citizens ' initiative , signatories shall be citizens of the union and shall be at least 16 years old .


### only statements of support forms which comply with the model set out in annex iii may be used for this purpose . the organiser shall complete the forms as indicated in annex iii prior to initiating the collection of statements of support from signatories . the information given in the forms shall correspond to the information contained in the register . ### only registered language versions of statements of support forms which comply with the model set out in annex iii may be used for this purpose . the organisers shall complete the forms as indicated in annex iii prior to initiating the collection of statements of support from signatories . the information given in the forms shall correspond to the information contained in the register .


### the treaty on european union reinforces the citizenship of the union and enhances further the democratic functioning of the union by providing inter alia that every citizen shall have the right to participate in the democratic life of the union and that not less than one million citizens who are nationals of a significant number of member states may take the initiative of inviting the european commission , within the framework of its powers , to submit any appropriate proposal on matters where citizens consider that a legal act of the union is required for the purpose of implementing the treaties . ### the treaty on european union reinforces the citizenship of the union and enhances further the democratic functioning of the union by providing inter alia that every citizen shall have the right to participate in the democratic life of the union by way of a european citizens ' initiative . that procedure affords citizens the possibility of directly approaching the commission , conferring on them a right of initiative similar to that exercised by the european parliament and the council .


### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organiser shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives as well as on the sources of funding and support for the proposed citizens ' initiative . this information shall be provided in one of the official languages of the union , in an online register made available for that purpose by the commission . ### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organisers shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives of the proposed citizens ' initiative . the organisers shall provide , for the register defined in the third subparagraph and where appropriate on their website , regularly updated information on the sources of support and funding for the initiative . this information shall be provided in one or more official languages of the union , in an online register made available for that purpose by the commission . information in an official language other the language in which it was originally provided may be provided subsequently for entry in the register . the translation of the initiative into other official languages of the union shall be the responsibility of the organisers .


### it is appropriate to provide that , where a citizens ' initiative has received the necessary statements of support from signatories and provided it is considered admissible , each member state should be responsible for the verification and certification of statements of support collected from citizens coming from that state . taking account of the need to limit the administrative burden for member states , they should , within a period of three months , carry out such verifications on the basis of appropriate checks and should issue a document certifying the number of valid statements of support received . ### in the absence of a competent union electoral authority , it is appropriate to provide that , where a citizens ' initiative has received the necessary statements of support from signatories , each member state should be responsible for the verification and certification of statements of support collected from citizens coming from that state . taking account of the need to limit the administrative burden for member states , they should , within a period of three months , carry out such verifications on the basis of appropriate checks , which may be based on random sampling , and should issue a document certifying the number of valid statements of support received .


### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , it is appropriate to clarify that the organiser of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subject to access to his / her personal data as well as the correction and erasure of his / her personal data . ### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , for the sake of legal certainty , it is appropriate to clarify that the organisers of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subjects to have access to their personal data as well as to procure the correction and erasure of their personal data .


### five years after the entry into force of this regulation , the commission shall present a report to the european parliament and the council on the implementation of this regulation . ### three years after the entry into force of this regulation , and every three years thereafter , the commission shall present a report to the european parliament and the council on the implementation of this regulation , with special emphasis on online collection systems and the application of transparency requirements concerning the funding of initiatives , together , if appropriate , with a legislative proposal for amendment of this regulation .


### for that purpose , it is also appropriate to establish the minimum number of citizens coming from each of those member states . in order to ensure similar conditions for citizens to support a citizens ' initiative , these minimum numbers should be degressively proportional to the size of each member state . for the purpose of clarity they should be set out for each member state in an annex to the present regulation . ### for that purpose , it is also appropriate to establish the minimum number of citizens coming from each of those member states . in order to ensure fair conditions for citizens of all nationalities , these minimum numbers should be degressively proportional according to the formula as agreed from time to time for the distribution of seats in the european parliament .


### after having obtained the certificates provided for in article 9 , and provided that all relevant procedures and conditions set out in this regulation have been complied with , the organiser may submit the citizens’ initiative to the commission . ### after having obtained the certificates provided for in article 9 , and provided that all relevant procedures and conditions set out in this regulation have been complied with , the organisers may submit the citizens’ initiative to the commission , accompanied by information regarding any support and funding received for the initiative . that information shall be published in the commission ' s register . the amount of support and funding received from any source in excess of which information is to be provided shall be identical to regulation no 2004 / 2003 of the european parliament and of the council of 4 november 2003 on the regulations governing political parties at european level and the rules regarding their funding1 . __________________________________ 1 oj l 297 , 15 . 11 . 2003 , p . 1 .


### ' citizens ' initiative ' means an initiative , submitted to the commission in accordance with the present regulation , inviting the commission , within the framework of its powers , to submit any appropriate proposal on matters where citizens consider that a legal act of the union is required for the purpose of implementing the treaties , which has received the support of at least one million eligible signatories coming from at least one third of all member states ; ### ' citizens ' initiative ' means an initiative , submitted to the commission in accordance with the present regulation , inviting the commission , within the framework of its powers , to submit any appropriate proposal on matters where citizens consider that a legal act of the union is required for the purpose of implementing the treaties , which has received the support of at least one million eligible signatories coming from at least one fifth of all member states ;


### after having collected the necessary statements of support from signatories in accordance with articles 5 and 7 , and provided that the commission has decided that a proposed citizens ' initiative is admissible in accordance with article 8 , the organiser shall submit the statements of support , in paper or in electronic form , to the relevant competent authorities provided for in article 14 for verification and certification . for this purpose the organiser shall use the form set out in annex vi . ### after having collected the necessary statements of support from signatories in accordance with articles 5 and 7 , the organisers shall submit the statements of support , in paper or in electronic form , to the relevant competent authorities provided for in article 14 for verification and certification . for this purpose the organisers shall use the form set out in annex vi .


### the competent authority shall destroy all statements of support and copies thereof that it has received for the purpose of carrying out the verification in accordance with article 9 , at the latest one month after issuing the certificate referred to therein . ### the competent authority shall destroy all statements of support and copies thereof that it has received for the purpose of carrying out the verification in accordance with article 9 , at the latest two months after issuing the certificate referred to therein . in the event of litigation they shall be destroyed one month after the conclusion of the litigation .


### the system can generate individual statements of support in a form complying with the model set out in annex iii , in order to allow for the control by the member states , in accordance with article 9 . ### the system can generate statements of support in a form complying with the model set out in annex iii , in order to allow for the control by the member states , in accordance with article 9 .


### the organiser shall destroy all statements of support received for a given citizens ' initiative and any copies thereof at the latest one month after submitting that initiative to the commission in accordance with article 10 or 18 months after the date of registration of a proposed citizens ' initiative , whichever is the earlier . ### unless the proceedings are the subject of litigation , the organiser shall destroy all statements of support received for a given citizens ' initiative and any copies thereof at the latest two months after the publication of the commission communication referred to in point of article 11 . in the event of litigation , they shall be destroyed one month after the conclusion of the litigation . save where the competent authorities of member states have not yet concluded their verification of statements of support , they shall also be destroyed if a proposed citizens ' initiative has not been submitted to the commission within 18 months after the date of its registration .


### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems . ### in order to put modern technology to good use as a tool of participatory democracy , it is appropriate to provide for statements of support to be collected online as well as in paper form . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person signs only once and that the data are securely stored . the detailed technical specifications should be worked out at an expert level and be regularly adapted to technical developments ; the power to adopt detailed technical specifications for online collection systems should therefore be delegated to the commission .


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . where the organiser is a legal person or an organisation it shall be established in a member state . organisations which do not have legal personality under the applicable national law shall have representatives that have the capacity to undertake legal obligations on their behalf and assume liability . ### organisers shall be citizens of the union and be of the age to be entitled to vote in the european elections .


### the organiser of a proposed citizens ' initiative should be responsible for the collection of the necessary statements of support from citizens . ### once a proposal is registered as a citizens ' initiative , statements of support from citizens may be collected by the organisers .


### where the commission receives a citizens ' initiative in accordance with article 10 it shall : publish the citizens ' initiative without delay on its website ; b . examine the citizens ' initiative and , within 4 months , set out in a communication its conclusions on the initiative , the action it intends to take , if any , and its reasons for doing so . ### where the commission receives a citizens ' initiative in accordance with article 10 it shall : publish the citizens ' initiative without delay on its website ; b . examine the citizens ' initiative , receive the organisers of the initiative at an appropriate level and , within three months , set out in a communication its initial conclusions on the initiative ; c . organise a public hearing jointly with the european parliament through its committee responsible , at which the commission shall be represented at commissioner or director - general level and at which the organisers shall have the opportunity to explain in detail the matters raised by the initiative ; d . present a legislative proposal within one year or include that proposal in its next year ' s work programme . if the commission does not present such a proposal it shall give the organisers as well as the european parliament and the council detailed explanations of its reasons for not acting on the initiative .


### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union for the purpose of amending the annexes to this regulation . ### with a view to the possible need in the future to amend or supplement certain non - essential elements in the provisions of this regulation or its annexes , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union .


### it is necessary to establish the minimum number of member states from which citizens must come . in order to ensure that a citizens ' initiative is representative of a union interest , this number should be set at one third of member states . ### it is necessary to establish a minimum number of member states from which citizens must come . this threshold should ensure that a citizens ' initiative is representative of a union interest but the requirements should not be too cumbersome . it therefore should be set at one fifth of the member states .


### after having obtained the certificates provided for in article 9 , and provided that all relevant procedures and conditions set out in this regulation have been complied with , the organiser may submit the citizens’ initiative to the commission . ### after having obtained the certificates provided for in article 9 , and provided that all relevant procedures and conditions set out in this regulation have been complied with , the organisers may submit the citizens’ initiative to the commission , accompanied by information regarding any support and funding received for the initiative . the amount of support and funding received from natural persons in excess of which information is to be provided shall be determined by the commission by means of delegated acts .


### the commission should examine a citizens ' initiative and set out its conclusions and the actions it envisages to take in response to it , within a period of four months . ### the commission should examine a citizens ' initiative and set out its legal and political conclusions separately ; it should also set out the actions it envisages to take in response to it . in order to demonstrate that a citizens ' initiative supported by at least one million union citizens and its possible follow - up is carefully examined , the commission should explain in a clear , comprehensible and detailed manner the reasons for its intended action , and should likewise give reasons if it does not envisage taking any action . as citizens should have the guarantee that a successful initiative will be subject of an official public hearing at union level , the institutions and bodies of the union should cooperate with a view to organising this debate .


### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organiser shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives as well as on the sources of funding and support for the proposed citizens ' initiative . this information shall be provided in one of the official languages of the union , in an online register made available for that purpose by the commission . ### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organisers shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives of the proposed citizens ' initiative . the organisers shall provide , for the register defined in the third subparagraph and where appropriate on their website , regularly updated information on the sources of support and funding for the initiative . this information shall be provided in one or more official languages of the union , in an online register made available for that purpose by the commission . information in an official language other the language in which it was originally provided may be provided subsequently for entry in the register . the translation of the initiative into other official languages of the union shall be the responsibility of the organisers .


### it is appropriate to provide that , where a citizens ' initiative has received the necessary statements of support from signatories and provided it is considered admissible , each member state should be responsible for the verification and certification of statements of support collected from citizens coming from that state . taking account of the need to limit the administrative burden for member states , they should , within a period of three months , carry out such verifications on the basis of appropriate checks and should issue a document certifying the number of valid statements of support received . ### it is appropriate to provide that , where a citizens ' initiative has received the necessary statements of support from signatories , each member state should be responsible for the verification and certification of statements of support collected from legally resident inhabitants of that member state . taking account of the need to limit the administrative burden for member states , they should , within a period of three months , carry out such verifications on the basis of appropriate checks , which may be based on random sampling , and should issue a document certifying the number of valid statements of support received .


### for that purpose , it is also appropriate to establish the minimum number of citizens coming from each of those member states . in order to ensure similar conditions for citizens to support a citizens ' initiative , these minimum numbers should be degressively proportional to the size of each member state . for the purpose of clarity they should be set out for each member state in an annex to the present regulation . ### for that purpose , it is also appropriate to establish the minimum number of citizens coming from each of those member states . in order to ensure fair conditions for citizens of all nationalities , these minimum numbers should be degressively proportional according to the formula as agreed from time to time for the distribution of seats in the european parliament .


### prior to initiating the collection of statements of support from signatories , the organiser shall ensure that the online collection system used for that purpose complies with the provisions of paragraph 4 . the organiser may , at any time , ask the relevant competent authority of the member state in which the data collected is or will be stored , to certify that the online collection system complies with those provisions . the organiser shall , in any case , request that certification prior to submitting statements of support for verification in accordance with article 9 . ### prior to initiating the collection of statements of support from signatories , the organisers shall ensure that the online collection system used for that purpose complies with the provisions of paragraph 4 . the organisers may , at any time , ask the relevant competent authority of the member state in which the data collected is or will be stored , to certify that the online collection system complies with those provisions . the organisers shall , in any case , request that certification prior to starting the collection of statements of support . the organiser shall make a copy of the certificate issued in that regard publicly available on the website used for the online collection system . within six months following the entry into force of this regulation , the commission shall make available an open - source software incorporating some of the technical and security features necessary for compliance with the provisions of this regulation regarding the online collection systems . the software shall be freely made available to organisers .


### only statements of support forms which comply with the model set out in annex iii may be used for this purpose . the organiser shall complete the forms as indicated in annex iii prior to initiating the collection of statements of support from signatories . the information given in the forms shall correspond to the information contained in the register . ### only registered language versions of statements of support forms which comply with the model set out in annex iii may be used for this purpose . the organisers shall complete the forms as indicated in annex iii prior to initiating the collection of statements of support from signatories . the information given in the forms shall correspond to the information contained in the register .


### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , it is appropriate to clarify that the organiser of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subject to access to his / her personal data as well as the correction and erasure of his / her personal data . ### directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data is fully applicable to the processing of personal data carried out in application of this regulation . in this respect , for the sake of legal certainty , it is appropriate to clarify that the organisers of a citizens ' initiative and the competent authorities of the member states are the data controllers within the meaning of directive 95 / 46 / ec and to specify the maximum period within which the personal data collected for the purposes of a citizens ' initiative may be retained . in their capacity as data controllers , organisers need to take all the appropriate measures to comply with the obligations imposed by directive 95 / 46 / ec , in particular those relating to the lawfulness of the processing , the security of the processing activities and the provision of information and the rights of data subjects to have access to their personal data as well as to procure the correction and erasure of their personal data .


### after having collected the necessary statements of support from signatories in accordance with articles 5 and 7 , and provided that the commission has decided that a proposed citizens ' initiative is admissible in accordance with article 8 , the organiser shall submit the statements of support , in paper or in electronic form , to the relevant competent authorities provided for in article 14 for verification and certification . for this purpose the organiser shall use the form set out in annex vi . ### after having collected the necessary statements of support from signatories in accordance with articles 5 and 7 , the organisers shall submit the statements of support , in paper or in electronic form , to the relevant competent authorities provided for in article 14 for verification and certification . for this purpose the organisers shall use the form set out in annex vi .


### in order to be eligible to support a proposed citizens ' initiative , signatories shall be citizens of the union and shall be of the age to be entitled to vote in the european elections . ### in order to be eligible to support a proposed citizens ' initiative , signatories shall be legally resident within the union and shall be at least 16 years of age .


### the organiser shall submit statements of support to the member state that issued the identification document indicated therein . ### the organisers shall submit statements of support to the member state where the signatories have their permanent residence or , in the case of signatories having their permanent residence in a third country , to the member state of which they are nationals .


### except in the cases foreseen in paragraphs 3 and 4 , the commission shall register without delay the proposed initiative under a unique registration number and send a confirmation to the organiser . ### if it is established that the proposed initiative qualifies as a citizens ' initiative pursuant to this regulation , the commission shall register it under a unique registration number and send a confirmation to the organisers .


### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the first day of the month following its publication in the official journal of the european union . it shall start to apply six months after its entry into force .


### within 12 months following the entry into force of this regulation , the commission shall adopt technical specifications for the implementation of paragraph 4 , in accordance with the regulatory procedure laid down in article 19 . ### within six months following the entry into force of this regulation , the commission shall adopt by means of delegated acts technical specifications for online collection systems .


### proposed citizens ' initiatives which can be reasonably regarded as improper because they are abusive or devoid of seriousness will not be registered . ### the commission shall register a proposed initiative within two months from its receipt when the following conditions are fulfilled : the citizens ' committee has been formed and the contact persons have been designated ; there are no manifest , significant inconsistencies between the linguistic versions of the title , subject - matter and objectives of the proposed initiative ; the initiative does not manifestly fall outside the scope of the commission’s power under the treaties to submit a proposal for the requested legal act ; the proposed initiative is not manifestly abusive , frivolous or vexatious ; the proposed initiative is not manifestly contrary to the values of the union as set out in article 2 of the treaty on european union .


### where the organiser is a natural person , that person shall be a citizen of the union and be of the age to be entitled to vote in the european elections . where the organiser is a legal person or an organisation it shall be established in a member state . organisations which do not have legal personality under the applicable national law shall have representatives that have the capacity to undertake legal obligations on their behalf and assume liability . ### organisers shall be citizens of the union and be of the age to be entitled to vote in the european elections .


### the treaty on european union reinforces the citizenship of the union and enhances further the democratic functioning of the union by providing inter alia that every citizen shall have the right to participate in the democratic life of the union and that not less than one million citizens who are nationals of a significant number of member states may take the initiative of inviting the european commission , within the framework of its powers , to submit any appropriate proposal on matters where citizens consider that a legal act of the union is required for the purpose of implementing the treaties . ### the treaty on european union reinforces the citizenship of the union and enhances further the democratic functioning of the union by providing inter alia that every citizen shall have the right to participate in the democratic life of the union by way of a european citizens ' initiative . that procedure affords citizens the possibility of directly approaching the commission , conferring on them a right of initiative similar to that exercised by the european parliament and the council .


### the commission should examine a citizens ' initiative and set out its conclusions and the actions it envisages to take in response to it , within a period of four months . ### the commission should examine a citizens ' initiative and respond to it in a clear , comprehensible and detailed manner and within a time frame corresponding to its handling of legislative initiatives of the european parliament under article 225 of the treaty on the functioning of the european union . thus , as a first step , the commission should receive the organisers within three months and inform them of how it intends to act . as a second step , the european commission should organise a public hearing jointly with the european parliament , through its responsible committee , with a representative of the commission in attendance as the main addressee . as a third step , the commission should come forward with its final response to the initiative after one year , either by proposing legislation accordingly or by explaining in a detailed manner its reasons for not acting on the initiative . the commission should also give a thorough explanation in the event that the legislative proposal diverges significantly from the citizens ' initiative .


### member states shall ensure that organisers resident or established on their territory shall be liable under their civil or criminal law for infringements of this regulation and in particular for : ### member states shall ensure that organisers resident on their territory shall be liable under their civil or criminal law for infringements of this regulation and in particular for :


### the identity of the person can be verified ; ### the fact that each person submits only one statement can be verified ;


### it is appropriate to provide for statements of support to be collected in paper form as well as online . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person can be identified and that the data are securely stored . for this purpose , the commission should be required to set out detailed technical specifications for online collection systems . ### in order to put modern technology to good use as a tool of participatory democracy , it is appropriate to provide for statements of support to be collected online as well as in paper form . online collection systems should have adequate security features in place in order to ensure , inter alia , that the person signs only once and that the data are securely stored . the detailed technical specifications should be worked out at an expert level and be regularly adapted to technical developments ; the power to adopt detailed technical specifications for online collection systems should therefore be delegated to the commission .


### the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by one month . ### the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by two months .


### within 12 months following the entry into force of this regulation , the commission shall adopt technical specifications for the implementation of paragraph 4 , in accordance with the regulatory procedure laid down in article 19 . ### within the 12 months following the entry into force of this regulation , the commission shall undertake in conjunction with the european data protection supervisor an evaluation enabling it to adopt technical specifications for the implementation of paragraph 4 , in accordance with the regulatory procedure laid down in article 19 . that evaluation shall be forwarded to the european parliament , together with the proposals .


### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organiser shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives as well as on the sources of funding and support for the proposed citizens ' initiative . this information shall be provided in one of the official languages of the union , in an online register made available for that purpose by the commission . ### prior to initiating the collection of statements of support from signatories for a proposed citizens ' initiative , the organisers shall be required to register it with the commission , providing the information set out in annex ii , in particular on the subject - matter and objectives of the proposed citizens ' initiative . the organisers shall provide , for the register defined in the third subparagraph and where appropriate on their website , regularly updated information on the sources of support and funding for the initiative . this information shall be provided in one or more official languages of the union , in an online register made available for that purpose by the commission . information in an official language other the language in which it was originally provided may be provided subsequently for entry in the register . the translation of the initiative into other official languages of the union shall be the responsibility of the organisers .


### the communication referred to in paragraph 1 shall be notified to the organiser of the citizens ' initiative as well as to the european parliament and the council and shall be made public . ### the communication referred to in paragraph 1 shall be notified to the organisers as well as to the european parliament and the council and shall be made public .


### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens ; proposals that are abusive or devoid of seriousness should not be registered and the commission should reject the registration of proposals which would be manifestly against the values of the union . the commission should deal with registration in accordance with the general principles of good administration . ### in order to ensure coherence and transparency in relation to proposed citizens ' initiatives and to avoid a situation in which signatures are collected for a proposal which does not fall within the scope of this regulation , it should be mandatory to register such initiatives on a website made available by the commission prior to collecting the necessary statements of support from citizens . proposals that are not citizens ' initiatives within the meaning of this regulation should not be registered . registration is an administrative procedure aimed at selecting those initiatives that fall within the scope of this regulation ; therefore any refusal of registration should be based only on legal grounds and not , on any account , on grounds of political expediency . the commission should deal with registration in accordance with the general principles of good administration , and should therefore be obliged to inform the organisers of an initiative of the reasons for any refusal to register that initiative and of all possible judicial and extrajudicial remedies available to them . it should also be made clear by the commission that registration and the collection of the required number of statements of support will not necessarily result in the commission adopting a proposal for a legal act and that the registration of an initiative does not constitute a formal decision on competence issues .


### the organiser of a proposed citizens ' initiative should be responsible for the collection of the necessary statements of support from citizens . ### once a proposal is registered as a citizens ' initiative , statements of support from citizens may be collected by the organisers .


### it is appropriate to establish and update a union list of vitamins , minerals , amino acids and other substances that may be added to infant formula , follow - on formula , processed cereal - based food and baby food , and food for special medical purposes , subject to certain criteria laid down in this regulation . given the fact that the adoption of the list implies the application of criteria set out in this regulation , implementing powers should be conferred on the commission in that respect . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the commission should adopt immediately applicable implementing acts updating the union list , where , in duly justified cases relating to public health , imperative grounds of urgency so require . ### it is appropriate to establish and update a union list of vitamins , minerals and other substances that may be added to infant formula , follow - on formula , processed cereal - based food and baby food , food for special medical purposes and food for use in energy - restricted diets , subject to certain criteria laid down in this regulation . the list should be adopted taking due account of the specific dietary habits of the population groups concerned and should take into account the lists set out in directives 2006 / 141 / ec and 2006 / 125 / ec and commission regulation no 953 / 2009 of 13 october 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses , which does not apply to liquid or solid formulae for infants and young children , and replace them . given the fact that the adoption of the list implies the application of criteria set out in this regulation , implementing powers should be conferred on the commission in that respect . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers . the commission should adopt immediately applicable implementing acts updating the union list , where , in duly justified cases relating to public health , imperative grounds of urgency so require .


### the entry of a substance in the union list referred to in paragraph 2 may be initiated either on the initiative of the commission or following an application . applications may be made by a member state or by an interested party , who may also represent several interested parties . applications shall be sent to the commission , in accordance with paragraph 4 . 4 . the application shall include : the name and the address of the applicant ; the name and a clear description of the substance ; the composition of the substance ; the proposed use of the substance and conditions thereof ; a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies ; scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses ; scientific evidence demonstrating that the substance is available for use by the human body ; a summary of the content of the application . 5 . when a substance is already included in the union list and there is a significant change in the production methods , or there is a change in particle size , for example through nanotechnology , the substance prepared by those new methods shall be considered as different substance and the union list shall be modified accordingly before it can be placed on the union market . ### article 11a updating of the union list the entry of a substance in the union list may be initiated either on the initiative of the commission or following an application . applications may be made by a member state or by an interested party , who may also represent several interested parties . applications shall be sent to the commission , in accordance with paragraph 2 . 2 . the application shall include : the name and the address of the applicant ; the name and a clear description of the substance ; the composition of the substance ; the proposed use of the substance and conditions thereof ; a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies ; scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses ; scientific evidence demonstrating that the substance is available for use by the human body ; a summary of the content of the application . 3 . where a substance is already included in the union list and there is a significant change in the production methods , the substance prepared by those new methods shall be considered as a different substance and shall be removed from the union list unless the union list is modified accordingly before it can be placed on the union market . 4 . if a substance that is on the union list no longer meets the conditions referred to in article 11 , the commission shall decide to remove that substance from the union list . 5 . the entry for a substance in the union list shall include : - a specification of the substance - where appropriate , a specification of the conditions of use , and - where appropriate , a specification of the applicable purity criteria . 6 . the commission shall update the union list by means of implementing regulations . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified imperative grounds of urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14


### 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 , food for special medical purposes and food intended for use in energy - restricted diets and they are presently covered by provisions laid down in commission directive 2006 / 141 / ec , commission directive 2006 / 125 / ec , as well as commission directive 1999 / 21 / ec and commission directive 96 / 8 / ec respectively . experience has shown that those provisions 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 focus 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 and food intended for use in energy - restricted diets and that the specific compositional and information requirements for these categories of food should be laid down by the commission in delegated regulations adopted pursuant to this regulation , which take into account and replace directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec and directive 96 / 8 / ec . the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of laying down the specific compositional and information requirements for the categories of food covered by this regulation , including additional labelling requirements to , or derogations from , the provisions of directive 2000 / 13 / ec and the authorisation of nutrition and health claims . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### the delegation of power referred to in articles 2 and 10 of this regulation shall be conferred for an indeterminate period of time from the [ date of entry into force of the basic legislative act or from any other date set by the legislator . ] ### the delegation of power referred to in articles 10 and 18a shall be conferred for a period of 5 years from the entry into force of this regulation . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### 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 and commission directive 96 / 8 / ec should be transferred to this regulation .


### the free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well - being of citizens , and to their social and economic interests . ### the safety of food , especially when it is intended for vulnerable groups , such as infants , young children and persons with special diseases , is an essential prerequisite for their free movement and the proper functioning of the internal market .


### ' meal replacement for weight control ' and ' total diet replacement for weight control ' are considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . in order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of union legislation , such 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 health claims referring to the body weight control for food presented as ' total diet replacement for weight control ' and as ' meal replacement for weight control ' and associated conditions of use as regulated under directive 96 / 8 / ec be completed prior to the entry into application of this regulation . ### ' meal replacement for weight control ' and ' total diet replacement for weight control ' are considered as food for particular nutritional uses and are governed by specific rules adopted under directive 96 / 8 / ec . however , more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control . against this background of the growing number of food products containing generic claims and the risk of disorders in dietary habits arising from certain unsupervised diets , the european food safety authority regularly carries out scientific assessments of health claim applications relating to meal replacement . the assessment carried out by the authority does not cover the safety of compositional criteria put forward by the operator applying for the use of a claim or certain labelling methods . it is therefore necessary to maintain specific provisions in this regulation on food for use in energy - restricted diets . this is an important nutrition and health safety tool for people seeking to lose weight .


### the free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well - being of citizens , and to their social and economic interests . ### the guarantee of safe and wholesome food products is an essential aspect of the internal market and contributes significantly to the health and well - being of citizens , particularly of vulnerable consumer groups , such as infants and young children , and to the social and economic interests of citizens . a better harmonization of rules will stimulate the free movement of goods and thus contribute to releasing the true potential of the internal market .


### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report concludes that the scientific basis for setting specific compositional requirements is lacking . ### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . with a view to the proper functioning of the internal market this category of food should be governed by regulation no 1924 / 2006 and should meet the requirements laid down in that regulation . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report concludes that the scientific basis for setting specific compositional requirements is lacking .


### at present , pursuant to the opinion of the scientific committee on emerging and newly identified health risks on the risk assessment of products of nanotechnologies , dated 19 january 2009 , there is inadequate information on the risks associated with engineered nanomaterials and existing test methods may not be sufficient to address all of the issues arising in relation to engineered nanomaterials . therefore , engineered nanomaterials should not be included in the union list for the categories of food covered by this regulation , until an evaluation by the authority is carried out . ### at present , pursuant to the opinion of the scientific committee on emerging and newly identified health risks on the risk assessment of products of nanotechnologies , dated 19 january 2009 , there is inadequate information on the risks associated with engineered nanomaterials and existing test methods may not be sufficient to address all of the issues arising in relation to engineered nanomaterials . taking account of this scientific opinion and in view of the particular sensitivity of the categories for which foods for particular uses are intended , engineered nanomaterials should not be included in the union list for the categories of food covered by this regulation so long as their safety and nutritional value have not been demonstrated by the authority .


### vitamins , minerals , amino acids and other substances may be added to food referred to in article 1 , provided that such substances meet the following conditions : they do not , on the basis of the scientific evidence available , pose a safety concern to the health of the consumer ; and b ) they are available for use by the human body . 2 . no later than [ 2 years after the date of the entry into force of this regulation ] , the commission shall establish and subsequently update a union list of permitted substances that meet the conditions of paragraph 1 , by means of implementing regulations . the entry of a substance in the union list shall include a specification of the substance , and , where appropriate , specify the conditions of use and the applicable purity criteria . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified grounds of extreme urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14 . ### taking account of the provisions of directives 2006 / 141 / ec and 2006 / 125 / ec and regulation no 953 / 2009 , no later than [ 2 years after the date of entry into force of this regulation ] the commission shall establish a union list of vitamins , minerals and other substances which may be added to the types of food referred to in article 1 . that list shall be different for each category of food referred to in article 1 . 2 . only the substances included in the union list may be added to the types of food referred to in article 1 . 3 . vitamins , minerals , amino acids and other substances may be added to food referred to in article 1 , provided that such substances meet the following conditions : they do not , on the basis of the scientific evidence available , pose a safety concern to the health of the consumer ; and b ) they are available for use by the human body . 4 . the commission shall establish the union list by means of implementing regulations . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 .


### the specific requirements on labelling , presentation and advertising of food referred to in article 1 , including the authorisation of nutrition and health claims thereof ; ### the specific requirements on labelling , presentation and advertising of food referred to in article 1 , including the authorisation of nutrition and health claims thereof , with the exception of infant formulae with their own rules regarding such claims ;


### the free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well - being of citizens , and to their social and economic interests . ### in order to guarantee the health and well - being of citizens , the safety of food products represents an essential requirement to their free circulation in the internal market , which , in turn , benefits european competitiveness by allowing a larger home market for companies .


### the delegation of powers referred to in articles 2 and 10 of this regulation may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles 10 and 18a of this regulation may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### 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 . experience has shown that the provisions laid down in directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec , regulation no 41 / 2009 , as well as 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 , taking into account directive 2006 / 141 / ec , directive 2006 / 125 / ec , directive 1999 / 21 / ec , directive 96 / 8 / ec and 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 using current union acts .


### general confidentiality clause 13 . the commission , the authority and the member states shall , in accordance with regulation no 1049 / 2001 , take the necessary measures to ensure appropriate confidentiality of the information received by them under this regulation , except for information which must be made public if circumstances so require in order to protect human health , animal health or the environment . ### general transparency and confidentiality clause 13 . the commission , the authority and the member states shall , in accordance with regulation no 1049 / 2001 , guarantee the broadest possible access to documents and , in particular , shall assist members of the public with and inform them about the procedures for submitting applications for access to documents . they shall also take the necessary measures to ensure appropriate confidentiality of the information received by them under this regulation , except for information which must be made public if circumstances so require in order to protect human health , animal health or the environment .


### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation , the number of sub - categories of the food to be included , the criteria for establishing composition requirements and the potential impact on innovation in product development . as regards special provisions for food for persons suffering from carbohydrate metabolism disorders , a commission report concludes that the scientific basis for setting specific compositional requirements is lacking . ### directive 2009 / 39 / ec foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particular nutritional uses : ' food intended to meet the expenditure of intense muscular effort , especially for sportsmen ' and ' food for persons suffering from carbohydrate metabolism disorders ' . with regard to food intended to meet the expenditure of intense muscular effort , no successful conclusion could be reached as regard the development of specific provisions due to widely diverging views among member states and stakeholders concerning the scope of the specific legislation . at the same time the undertaking made by the commission in directive 2009 / 39 / ec to meet the high demand from persons engaging in sports and to clarify the relevant labelling rules still applies , which certainly justifies the commission’s updating of the report of 28 february 2001 on the foods concerned .


### 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 shall neither attribute to such products properties for the prevention , treatment or cure of human disease nor imply such properties .


### the entry of a substance in the union list referred to in paragraph 2 may be initiated either on the initiative of the commission or following an application . applications may be made by a member state or by an interested party , who may also represent several interested parties . applications shall be sent to the commission , in accordance with paragraph 4 . 4 . the application shall include : the name and the address of the applicant ; the name and a clear description of the substance ; the composition of the substance ; the proposed use of the substance and conditions thereof ; a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies ; scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses ; scientific evidence demonstrating that the substance is available for use by the human body ; a summary of the content of the application . 5 . when a substance is already included in the union list and there is a significant change in the production methods , or there is a change in particle size , for example through nanotechnology , the substance prepared by those new methods shall be considered as different substance and the union list shall be modified accordingly before it can be placed on the union market . ### article 11a updating of the union list the entry of a substance in the union list may be initiated either on the initiative of the commission or following an application . applications may be made by a member state or by an interested party , who may also represent several interested parties . applications shall be sent to the commission , in accordance with paragraph 2 . 2 . the application shall include : the name and the address of the applicant ; the name and a clear description of the substance ; the composition of the substance ; the proposed use of the substance and conditions thereof ; a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies ; scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses ; scientific evidence demonstrating that the substance is available for use by the human body ; a summary of the content of the application . 3 . where a substance is already included in the union list and there is a significant change in the production methods , the substance prepared by those new methods shall be considered as a different substance and shall be removed from the union list unless the union list is modified accordingly before it can be placed on the union market . 4 . if a substance that is on the union list no longer meets the conditions referred to in article 11 , the commission shall decide to remove that substance from the union list . 5 . the entry for a substance in the union list shall include : - a specification of the substance - where appropriate , a specification of the conditions of use , and - where appropriate , a specification of the applicable purity criteria . 6 . the commission shall update the union list by means of implementing regulations . those implementing regulations shall be adopted in accordance with the examination procedure referred to in article 14 . on duly justified imperative grounds of urgency relating to emerging health risks , the commission shall adopt immediately applicable implementing acts updating the union list in accordance with article 14


### – carrying out a minimum activity to be established by member states on agricultural areas naturally kept in a state suitable for grazing or cultivation ; ### – carrying out a minimum annual activity to be established by member states on agricultural areas naturally kept in a state suitable for grazing or cultivation ;


### where the commission has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation . ### where the esrb has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with this regulation and the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial market participants and competent authorities satisfy the requirements laid down in that legislation .


### the board of supervisors shall act on the basis of qualified majority of its members , as defined in article 205 of the treaty , for acts specified in articles 7 , 8 and all measures and decisions adopted under chapter vi . ### the board of supervisors shall act on the basis of qualified majority of its members , as defined in article 16 of the eu treaty and in article 3 of the protocol on transitional provisions annexed to the treaty on european union and to the treaty on the functioning of the european union .